PDA BioManufacturing Conference 2024

Tuesday, 24 September CEST

• 08:00 – 18:00

  Registration Open

  Övre Verandan
• 09:00 – 09:10

  Welcoming

  Banquet Hall 1

  • Committee Member: Falk Klar, PhD, General Manager, Vice President Europe, Parenteral Drug Association

    

    Falk Klar, PhD, General Manager, Vice President Europe, Parenteral Drug Association
    

    Falk Klar holds a Ph.D. in Applied Physics and has over 19 years of experience in Quality Assurance and Compliance in the life science industry. Falk held positions in pre-clinical research and development in a medical product company and clinical research in a CRO. He has gained experience with biopharmaceutical and pharmaceutical products including monoclonal antibodies, vaccines, parenteral, narcotics, and animal drugs in several positions in quality management. Falk joined PDA Europe in 2015 as Senior Director of Training & Education. Since 2016 he has been appointed General Manager and Vice President of PDA Europe.
• 09:10 – 09:20

  Welcome from the Co-Chair

  Banquet Hall 1

  • Co-Chair: Sabine Hauck, Dr, Consultant, _

    

    Sabine Hauck, Dr, Consultant, _
    

    Sabine Hauck has 20+ years of experience in the biotech industry, in which she held various positions in pharmaceutical development, quality assurance and regulatory affairs. Her experience spans from small molecules to cell therapies and includes a variety of dosage forms.Currently, Sabine is a freelance consultant for biopharma product development and is CTO of Thermosome.
• 09:20 – 10:50

  Opening Plenary Part I: Addressing Patients Needs

  Banquet Hall 1

  • Moderator: Cristiana Campa, PhD, Technical R&D Advisor, GSK

    

    Cristiana Campa, PhD, Technical R&D Advisor, GSK
    

    Cristiana Campa, PhD, is currently a Technical R&D Advisor at GSK Vaccines, with involvement in CMC development portfolio support and scientific advocacy, focusing on CMC strategies and innovation, with active participation in several cross-company working groups (e.g.,PDA, EFPIA/ Vaccines Europe, IFPMA). She has more than 20 years experience in biologics and related analytical and development approaches, gained in different universities and companies. She joined Novartis Vaccines in 2006, focusing on development, validation and transfer of analytical methods for release and characterization of several vaccine products, first as senior manager and then as Head of Analytical Development, Italy. Since 2012, Cristiana has worked on Quality by Design (QbD) principles implementation for vaccines. After acquisition of Novartis Vaccines by GSK in 2015, she has been the Head of QbD Integration and, until June 2018, the Head of Science and Development Practices in Technical R&D, covering QbD implementation, Knowledge Management and Development roadmaps. Since 2023, Cristiana is an elected member of the PDA Board of Directors. Since 2024, she is the co-chair of the PDA Vaccine Interest Group, and a member of the ICH Expert Working Group dedicated to ICHQ6 Guideline (Specifications) revision (EFPIA lead).

  With the theme of this year: Shaping the Future of Biomanufacturing the 6th PDA Biomanufacturing Conference provides you with key trends and latest development in Bioindustry. The first plenary session will focus on our core motivations: serving the patient’s needs with an exceptional patient testimony followed by an overview of modern treatment modalities and the current key trends. The regulatory talk will focus then on the update of the ICH Q6.

  • 09:20 – 09:50

    A Brief Insight Into Life with Multiple Sclerosis

    • Presenter: Karen Lynn Mayra Somers, /, /

      

      Karen Lynn Mayra Somers, /, /
      

      My name is Karen Somers. I have been living with multiple sclerosis for ten years. At the conference I will talk about the disease and what the impact has been on my life. Except from that I have a medical degree and for the moment I am following the residency program for occupational medicine in Belgium.

  • 09:50 – 10:20

    Development of Antibody Drug Conjugates as Specific and Potent Medicinal Products - A Regulator's Perspective

    • Regulatory Presenter: Steffen Gross, Head Section Qualtiy and Non-clinical Evaluation of Antibody Therapeutics, Paul-Ehrlich-Institute

      

      Steffen Gross, Head Section Qualtiy and Non-clinical Evaluation of Antibody Therapeutics, Paul-Ehrlich-Institute
      

      Steffen Gross has extensive experience in molecular and cell biology. Mr. Gross joined the Paul-Ehrlich Institute in 2005 and became Head of the Section monoclonal and polyclonal antibodies in 2012. Due to re-structure of the section he became Head of Section Quality and Non-clinical Evaluation of Antibody therapeutics” in 2022. He is involved in the assessment of the quality and preclinical issues for marketing authorization applications, scientific advices and clinical trial applications. Until 2012 Mr. Gross was laboratory head of the section monoclonal and polyclonal antibodies and involved in testing of immunoglobulins, immunosera and monoclonal antibodies. Before joining the Paul-Ehrlich Institute he worked in the Netherland for three years as a postdoc. During this time he had been working several months at the National Institute of Health in Bethesda. After his return to Germany in 2001 he became a research group leader at the University of Frankfurt.

  • 10:20 – 10:50

    ICH Q6 - Quo Vadis

    • Regulatory Presenter: Mats Welin, MScPharm, Scientific director, Biotechnology, Medical Products Agency, Sweden

      

      Mats Welin, MScPharm, Scientific director, Biotechnology, Medical Products Agency, Sweden
      

      Mats Welin holds a position as a Senior expert at the Medical Products Agency in Sweden, working with quality assessment of human and veterinary biologics and normative work within this field. He is a pharmacist by training and has been employed at the agency since 1988. Since 1996 he is the Swedish delegate of CHMPs sub group on biologics, the Biologics working party (BWP) and has in addition to assessments of MAAs and scientific advices also been involved in writing of many guidelines and other normative work in the field as well as been involved in EMA-Industry workshops on setting of specifications, QbD, prior knowledge and accelerated procedures. He is an alternate Swedish delegate to the European Pharmacopoeial Commission and have been involved in WHO work, in particular on requirements to post approval changes to human vaccines. He is the EU regulator topic lead in the revision of ICH Q6 on specifications and was also a delegate of the Quality implementation working group (Q-IWG) of the ICH to work with introduction of the Q8-Q10 concepts. He is frequent speaker at conferences on Quality by Design, process validation, setting of specifications and on general aspects in relation to biological medicinal products.

• 10:50 – 11:20

  Networking Coffee Break, Poster Session & Exhibition

  Övre Verandan
• 11:20 – 12:30

  Opening Plenary Part II: Addressing Patients Needs

  Banquet Hall 1

  • Moderator: Cristiana Campa, PhD, Technical R&D Advisor, GSK

    

    Cristiana Campa, PhD, Technical R&D Advisor, GSK
    

    Cristiana Campa, PhD, is currently a Technical R&D Advisor at GSK Vaccines, with involvement in CMC development portfolio support and scientific advocacy, focusing on CMC strategies and innovation, with active participation in several cross-company working groups (e.g.,PDA, EFPIA/ Vaccines Europe, IFPMA). She has more than 20 years experience in biologics and related analytical and development approaches, gained in different universities and companies. She joined Novartis Vaccines in 2006, focusing on development, validation and transfer of analytical methods for release and characterization of several vaccine products, first as senior manager and then as Head of Analytical Development, Italy. Since 2012, Cristiana has worked on Quality by Design (QbD) principles implementation for vaccines. After acquisition of Novartis Vaccines by GSK in 2015, she has been the Head of QbD Integration and, until June 2018, the Head of Science and Development Practices in Technical R&D, covering QbD implementation, Knowledge Management and Development roadmaps. Since 2023, Cristiana is an elected member of the PDA Board of Directors. Since 2024, she is the co-chair of the PDA Vaccine Interest Group, and a member of the ICH Expert Working Group dedicated to ICHQ6 Guideline (Specifications) revision (EFPIA lead).

  With the theme of this year: Shaping the Future of Biomanufacturing the 6th PDA Biomanufacturing Conference provides you with key trends and latest development in Bioindustry. The first plenary session will focus on our core motivations: serving the patient’s needs with an exceptional patient testimony followed by an overview of modern treatment modalities and the current key trends. The regulatory talk will focus then on the update of the ICH Q6.

  • 11:20 – 11:45

    Developing Patient Centric Specification for Commercial Biologics: Real World Case Studies

    • Presenter: Jason Warfel

      

      Jason Warfel
      

  • 11:45 – 12:30

    Plenary Discussion

    • Moderator: Cristiana Campa, PhD, Technical R&D Advisor, GSK

      

      Cristiana Campa, PhD, Technical R&D Advisor, GSK
      

      Cristiana Campa, PhD, is currently a Technical R&D Advisor at GSK Vaccines, with involvement in CMC development portfolio support and scientific advocacy, focusing on CMC strategies and innovation, with active participation in several cross-company working groups (e.g.,PDA, EFPIA/ Vaccines Europe, IFPMA). She has more than 20 years experience in biologics and related analytical and development approaches, gained in different universities and companies. She joined Novartis Vaccines in 2006, focusing on development, validation and transfer of analytical methods for release and characterization of several vaccine products, first as senior manager and then as Head of Analytical Development, Italy. Since 2012, Cristiana has worked on Quality by Design (QbD) principles implementation for vaccines. After acquisition of Novartis Vaccines by GSK in 2015, she has been the Head of QbD Integration and, until June 2018, the Head of Science and Development Practices in Technical R&D, covering QbD implementation, Knowledge Management and Development roadmaps. Since 2023, Cristiana is an elected member of the PDA Board of Directors. Since 2024, she is the co-chair of the PDA Vaccine Interest Group, and a member of the ICH Expert Working Group dedicated to ICHQ6 Guideline (Specifications) revision (EFPIA lead).

    • Regulatory Panelist: Steffen Gross, Head Section Qualtiy and Non-clinical Evaluation of Antibody Therapeutics, Paul-Ehrlich-Institute

      

      Steffen Gross, Head Section Qualtiy and Non-clinical Evaluation of Antibody Therapeutics, Paul-Ehrlich-Institute
      

      Steffen Gross has extensive experience in molecular and cell biology. Mr. Gross joined the Paul-Ehrlich Institute in 2005 and became Head of the Section monoclonal and polyclonal antibodies in 2012. Due to re-structure of the section he became Head of Section Quality and Non-clinical Evaluation of Antibody therapeutics” in 2022. He is involved in the assessment of the quality and preclinical issues for marketing authorization applications, scientific advices and clinical trial applications. Until 2012 Mr. Gross was laboratory head of the section monoclonal and polyclonal antibodies and involved in testing of immunoglobulins, immunosera and monoclonal antibodies. Before joining the Paul-Ehrlich Institute he worked in the Netherland for three years as a postdoc. During this time he had been working several months at the National Institute of Health in Bethesda. After his return to Germany in 2001 he became a research group leader at the University of Frankfurt.

    • Regulatory Panelist: Mats Welin, MScPharm, Scientific director, Biotechnology, Medical Products Agency, Sweden

      

      Mats Welin, MScPharm, Scientific director, Biotechnology, Medical Products Agency, Sweden
      

      Mats Welin holds a position as a Senior expert at the Medical Products Agency in Sweden, working with quality assessment of human and veterinary biologics and normative work within this field. He is a pharmacist by training and has been employed at the agency since 1988. Since 1996 he is the Swedish delegate of CHMPs sub group on biologics, the Biologics working party (BWP) and has in addition to assessments of MAAs and scientific advices also been involved in writing of many guidelines and other normative work in the field as well as been involved in EMA-Industry workshops on setting of specifications, QbD, prior knowledge and accelerated procedures. He is an alternate Swedish delegate to the European Pharmacopoeial Commission and have been involved in WHO work, in particular on requirements to post approval changes to human vaccines. He is the EU regulator topic lead in the revision of ICH Q6 on specifications and was also a delegate of the Quality implementation working group (Q-IWG) of the ICH to work with introduction of the Q8-Q10 concepts. He is frequent speaker at conferences on Quality by Design, process validation, setting of specifications and on general aspects in relation to biological medicinal products.

    • Panelist: Jason Warfel

      

      Jason Warfel
      

    • Panelist: Karen Lynn Mayra Somers, /, /

      

      Karen Lynn Mayra Somers, /, /
      

      My name is Karen Somers. I have been living with multiple sclerosis for ten years. At the conference I will talk about the disease and what the impact has been on my life. Except from that I have a medical degree and for the moment I am following the residency program for occupational medicine in Belgium.

• 12:30 – 13:45

  Networking Lunch Break & Exhibition

  Övre Verandan
• 13:15 – 13:45

  Guided Poster Walk

  Taubesalen

  • Moderator: Bianca Bohrer, Dipl Ing, Managing Director, PSM GmbH

    

    Bianca Bohrer, Dipl Ing, Managing Director, PSM GmbH
    

    Ms. Bianca Bohrer studied pharmaceutical technology at the University of Applied Sciences in Kiaserslautern. Early on, she gained experience in GMP-compliant work, especially in the area of qualification. As a division manager for analytical chemistry and as a manufacturing manager for parenteral applications, she was able to further deepen these skills. Since September 2014 she has been Head of Quality Control, since 2019 Managing Director of PharmBioTec GmbH, a non-profit research institute, and since 2020 Managing Director of PSM GmbH - a §13-AMG contract manufacturers for aseptic products.

  • 13:15 – 13:45

    Biodecontamination of Raw Materials in Packaging Production Process

    • Poster Presenter: Andrea Weiss

      

      Andrea Weiss
      

  • 13:15 – 13:45

    Evaluation of a Novel Freeze/Thaw Device for Drug Substance Bottles – A Case Study

    • Poster Presenter: Sarah S. Peláez, PhD Student & Senior Scientist Primary Packaging, ten23 health

      

      Sarah S. Peláez, PhD Student & Senior Scientist Primary Packaging, ten23 health
      

      Sarah Peláez works as a PhD Student and Senior Scientist in the primary packaging and manufacturing group at ten23 health, a CDMO founded in 2021 in Basel (Switzerland). Before she joined ten23 health in 2021, she worked three years at Lonza in different groups, including the phys.-chem. analytical department and in primary packaging and device development. Sarah is experienced in the development of container closure systems (CCS) for parenteral drug products. Her current research focuses on process characterization of disposable materials used in biopharmaceutical manufacturing. She holds a BSc and MSc degree in Life Sciences, Pharmaceutics from the University of Applied Sciences and Arts Northwestern Switzerland, and is currently enrolled in a PhD program at the University of Frankfurt.

  • 13:15 – 13:45

    Implementing X-Ray for Single Use Systems Sterilization: Current Status

    • Poster Presenter: Samuel Dorey, PhD, Principal Scientist Materials & Irradiations, Sartorius

      

      Samuel Dorey, PhD, Principal Scientist Materials & Irradiations, Sartorius
      

      Samuel has a strong focus on the radiation application work covering a wide range of applications including radiation effects on SUS for biopharmaceutical processes. Samuel is also deeply involved in promoting and facilitating the application of alternative ionizing radiations to gamma. He's the co-chair of the BPSA X-ray-committee, whose objective is to focus on the irradiation sterilization future in the form of X-ray, as increasing capacity constraints impact delivery for the growing single-use market. He is one of the lead authors of the 2021 BPSA technical guide, titled “X-Ray Sterilization of SUS”. He’s also member of the ASTM E61 and of the Panel of Gamma and Electron Irradiation. Samuel is also part of the Team Nablo initiative to conduct and spread-out specific material compatibility upon the different irradiation modalities. He's one of the lead panelists with the Emerging Technology Team (ETT) at the FDA and BARDA to discuss technology proposal on X-ray sterilization of Single-Use bioprocess equipments for biopharmaceutical manufacturing since 2021. He's also the authors/co-authors of ~20 pear reviewed articles on gamma/X-ray/Ebeam impacts on plastic materials. Samuel is Principal Scientist, Materials and Irradiations, within Sartorius Product Development. He received a PhD in Polymer Science from the Mulhouse University, France.

  • 13:15 – 13:45

    Investigation of Mechanical Stability and Product Quality of Lyophilized Biopharmaceuticals During Shaking

    • Poster Presenter: Natalie Hoerberger

      

      Natalie Hoerberger
      

  • 13:15 – 13:45

    Label-free Single Cell PAT Precision Analytics for Cell & Gene Therapies & Vaccines, Enabling Higher Product Consistency, Quality & Yields

    • Poster Presenter: Christof Hasse

      

      Christof Hasse
      

  • 13:15 – 13:45

    Lifecycle Management of a Commercial Platform Monoclonal Antibody Process: Understanding the Impact of Raw Material Variability and Its Impact on Supply Resilience

    • Poster Presenter: Will Pierce

      

      Will Pierce
      

  • 13:15 – 13:45

    Microwave-Assisted Freeze-Drying of Biopharmaceuticals

    • Poster Presenter: Nicole Haerdter

      

      Nicole Haerdter
      

  • 13:15 – 13:45

    Single-Use System Integrity as Foundation for a Successful Contamination Control Strategy

    • Poster Presenter: Cecilia Annerén

      

      Cecilia Annerén
      

  • 13:15 – 13:45

    Univessel® SU 10 L: Development of a New, Single-Use Bioreactor Portfolio Capable of Addressing Both Established & Emerging Therapeutic Modalities

    • Poster Presenter: John Betts

      

      John Betts
      

• 13:45 – 15:30

  Session 1 Track A: Processes for New Entities in Freeze-Drying

  Banquet Hall 1

  • Moderator: Julian H. Lenger, PhD, Head of Laboratory Parenteral Drug Development, Bayer AG

    

    Julian H. Lenger, PhD, Head of Laboratory Parenteral Drug Development, Bayer AG
    

    Dr. Julian Lenger is a pharmacist by training with expertise in established and novel freeze-drying technologies as well as formulation development and analytical characterization of biotherapeutics and small molecules. Since 2020, he is driving formulation and process development for development projects at Bayer AG in Wuppertal, Germany, as Head of Laboratory in Drug Product Development for parenteral drugs. Before joining Bayer, Julian spent four years as PhD student at the Ludwig-Maximilians-Universität München (University of Munich, Germany) in the group of Prof. Dr. Gerhard Winter at the chair of pharmaceutical technology. Here he successfully investigated and published several papers on novel technologies like microwave-assisted freeze-drying or controlled ice nucleation. Previously, Julian studied Pharmacy at the Christian-Albrechts-Universität zu Kiel (University of Kiel, Germany) and Trinity College Dublin, Ireland. Besides Julian is an active member in societies and consortia like Parenteral Drug Association (PDA) and BioPhorum.

  Unlock the future of biomanufacturing with our session on freeze-drying processes, featuring experts unveiling the latest advancements and technologies. Discover how cutting-edge technologies like vial impedance spectroscopy and Hydrogen Deuterium Mass Spectrometry can revolutionize the stability of biologics, offering you the keys to mastering protein stabilization. Dive into a state-of-the-art lyophilization model that seamlessly integrates thermodynamic principles with heat and mass transfer equations, empowering you to optimize process parameters and ensure unparalleled product quality through predictive modeling and robustness analysis. Uncover innovative solutions to the logistical challenges of oncolytic viruses, including a pioneering formulation that stabilizes these entities for easy distribution and storage at 2-8 °C, potentially transforming clinical applications and slashing costs. This session is designed to not only inform but also ignite your creativity, driving the next wave of innovation in biopharmaceutical manufacturing. Stay ahead of the curve and elevate your expertise in freeze-drying technology.

  Track A

  • 13:45 – 14:10

    Developments in In-Line and Off-Line Analytics Applied to Freeze Drying of Biologicals

    • Presenter: Paul Matejtschuk, PhD FRSC CChem, Section Head Formulation Science, MHRA

      

      Paul Matejtschuk, PhD FRSC CChem, Section Head Formulation Science, MHRA
      

      Biography: Paul Matejtschuk PhD, CChem, FRSC leads the Formulation Science Section at the Medicines and Healthcare products Regulatory Agency, at their South Mimms laboratories, in the UK, whose mission is to safeguard the quality of biological medicines. He has over 20 years experience of developing freeze drying and formulation conditions for a wide range of biological materials including those developed on behalf of the WHO as International Reference Standards for Biological Standardization. His team is focused on delivering formulation and lyophilization conditions and his research interests include Process Analytical Technology in freeze drying, the relationship between structure and stability in biologicals, thermal analysis and other methods for the characterization of lyophilized proteins. Paul Matejtschuk (0000-0002-4646-800X) - ORCID Paul has over 35 years postdoctoral experience working in both academic and industrial settings in the areas of biologicals, with broad experience across downstream processing, characterization and analysis. He is a Director of the International Society for Lyophilization/Freeze Drying (www.islyophilization.org) and a committee member of the Thermal Methods Group of the Royal Society of Chemistry (www.thermalmethodsgroup.org.uk). Email: paul.matejtschuk@mhra.gov.uk

  • 14:10 – 14:35

    Building Robustness into the Primary Drying Phase of Lyophilization: A Modelling Framework and Use Cases for Biopharmaceuticals

    • Presenter: Andrea Arsiccio, PhD, Senior Scientist, Coriolis Pharma

      

      Andrea Arsiccio, PhD, Senior Scientist, Coriolis Pharma
      

      Andrea Arsiccio is a Senior Scientist at Coriolis Pharma, where he works on projects dealing with lyophilization process development and the implementation of innovative modelling concepts. He received a master's degree in Chemical Engineering from Politecnico di Torino in 2016 followed by a PhD degree in 2020. During his PhD he investigated the freeze drying process, with a special focus on the formulation of biopharmaceuticals. He subsequently worked as a Postdoctoral scholar at the University of California in Santa Barbara and at Politecnico di Torino, and during this time his research focused on molecular dynamics simulations and bioinformatics. His main interests and expertise are in the fields of freeze drying, protein folding and aggregation, and molecular dynamics simulations.

  • 14:35 – 15:00

    Solving the Deep-Frozen Challenge – Lyophilization of an Oncolytic Virus

    • Presenter: Thomas Kriehuber, PhD, Head of Development Center Drug Product, Boehringer Ingelheim

      

      Thomas Kriehuber, PhD, Head of Development Center Drug Product, Boehringer Ingelheim
      

      After his PhD in Biochemistry, Thomas Kriehuber came into contact with formulation and drug product development at Leukocare as project manager for customer projects. In 2018, Thomas decided to take over responsibility for a development lab in the Pharmaceutical Development Biologics department at Boehringer Ingelheim in Biberach and is now heading the development center Drug Product in the newly established Viral Therapeutic Center.

  • 15:00 – 15:30

    Q&A

    • Moderator: Julian H. Lenger, PhD, Head of Laboratory Parenteral Drug Development, Bayer AG

      

      Julian H. Lenger, PhD, Head of Laboratory Parenteral Drug Development, Bayer AG
      

      Dr. Julian Lenger is a pharmacist by training with expertise in established and novel freeze-drying technologies as well as formulation development and analytical characterization of biotherapeutics and small molecules. Since 2020, he is driving formulation and process development for development projects at Bayer AG in Wuppertal, Germany, as Head of Laboratory in Drug Product Development for parenteral drugs. Before joining Bayer, Julian spent four years as PhD student at the Ludwig-Maximilians-Universität München (University of Munich, Germany) in the group of Prof. Dr. Gerhard Winter at the chair of pharmaceutical technology. Here he successfully investigated and published several papers on novel technologies like microwave-assisted freeze-drying or controlled ice nucleation. Previously, Julian studied Pharmacy at the Christian-Albrechts-Universität zu Kiel (University of Kiel, Germany) and Trinity College Dublin, Ireland. Besides Julian is an active member in societies and consortia like Parenteral Drug Association (PDA) and BioPhorum.

    • Panelist: Andrea Arsiccio, PhD, Senior Scientist, Coriolis Pharma

      

      Andrea Arsiccio, PhD, Senior Scientist, Coriolis Pharma
      

      Andrea Arsiccio is a Senior Scientist at Coriolis Pharma, where he works on projects dealing with lyophilization process development and the implementation of innovative modelling concepts. He received a master's degree in Chemical Engineering from Politecnico di Torino in 2016 followed by a PhD degree in 2020. During his PhD he investigated the freeze drying process, with a special focus on the formulation of biopharmaceuticals. He subsequently worked as a Postdoctoral scholar at the University of California in Santa Barbara and at Politecnico di Torino, and during this time his research focused on molecular dynamics simulations and bioinformatics. His main interests and expertise are in the fields of freeze drying, protein folding and aggregation, and molecular dynamics simulations.

    • Panelist: Thomas Kriehuber, PhD, Head of Development Center Drug Product, Boehringer Ingelheim

      

      Thomas Kriehuber, PhD, Head of Development Center Drug Product, Boehringer Ingelheim
      

      After his PhD in Biochemistry, Thomas Kriehuber came into contact with formulation and drug product development at Leukocare as project manager for customer projects. In 2018, Thomas decided to take over responsibility for a development lab in the Pharmaceutical Development Biologics department at Boehringer Ingelheim in Biberach and is now heading the development center Drug Product in the newly established Viral Therapeutic Center.

    • Panelist: Paul Matejtschuk, PhD FRSC CChem, Section Head Formulation Science, MHRA

      

      Paul Matejtschuk, PhD FRSC CChem, Section Head Formulation Science, MHRA
      

      Biography: Paul Matejtschuk PhD, CChem, FRSC leads the Formulation Science Section at the Medicines and Healthcare products Regulatory Agency, at their South Mimms laboratories, in the UK, whose mission is to safeguard the quality of biological medicines. He has over 20 years experience of developing freeze drying and formulation conditions for a wide range of biological materials including those developed on behalf of the WHO as International Reference Standards for Biological Standardization. His team is focused on delivering formulation and lyophilization conditions and his research interests include Process Analytical Technology in freeze drying, the relationship between structure and stability in biologicals, thermal analysis and other methods for the characterization of lyophilized proteins. Paul Matejtschuk (0000-0002-4646-800X) - ORCID Paul has over 35 years postdoctoral experience working in both academic and industrial settings in the areas of biologicals, with broad experience across downstream processing, characterization and analysis. He is a Director of the International Society for Lyophilization/Freeze Drying (www.islyophilization.org) and a committee member of the Thermal Methods Group of the Royal Society of Chemistry (www.thermalmethodsgroup.org.uk). Email: paul.matejtschuk@mhra.gov.uk

• 13:45 – 15:30

  Session 1 Track B: CMC Strategies for Vaccines Biomanufacturing

  Banquet Hall 2

  • Moderator: Cristiana Campa, PhD, Technical R&D Advisor, GSK

    

    Cristiana Campa, PhD, Technical R&D Advisor, GSK
    

    Cristiana Campa, PhD, is currently a Technical R&D Advisor at GSK Vaccines, with involvement in CMC development portfolio support and scientific advocacy, focusing on CMC strategies and innovation, with active participation in several cross-company working groups (e.g.,PDA, EFPIA/ Vaccines Europe, IFPMA). She has more than 20 years experience in biologics and related analytical and development approaches, gained in different universities and companies. She joined Novartis Vaccines in 2006, focusing on development, validation and transfer of analytical methods for release and characterization of several vaccine products, first as senior manager and then as Head of Analytical Development, Italy. Since 2012, Cristiana has worked on Quality by Design (QbD) principles implementation for vaccines. After acquisition of Novartis Vaccines by GSK in 2015, she has been the Head of QbD Integration and, until June 2018, the Head of Science and Development Practices in Technical R&D, covering QbD implementation, Knowledge Management and Development roadmaps. Since 2023, Cristiana is an elected member of the PDA Board of Directors. Since 2024, she is the co-chair of the PDA Vaccine Interest Group, and a member of the ICH Expert Working Group dedicated to ICHQ6 Guideline (Specifications) revision (EFPIA lead).

  This session will provide some insights into CMC's innovative Strategies for Vaccines Biomanufacturing, covering development and lifecycle considerations. We will start with an overview of PDA Vaccine Interest Group (VIG) activities in this field, reporting recent activities and key topics of interest voted by PDA vaccine experts. Ideas and comments from the audience will be taken into consideration by the PDA VIG and reflected in future VIG tasks as needed. The session will then propose industry examples of “patient-centric” CMC strategies, based on experience from two vaccine manufacturers; reflection on product (formulation) development and specifications setting will be offered, illustrating challenges and opportunities associated with different vaccine types.

  Track B

  • 13:45 – 14:10

    Vaccines Interest Group Session - Our 2024 journey!

    • Presenter: Sabrina Restrepo, PhD, Director, Vaccines - Technical Product Leadership, Merck & Co., Inc.

      

      Sabrina Restrepo, PhD, Director, Vaccines - Technical Product Leadership, Merck & Co., Inc.
      

      Sabrina's responsibilities at Merck have included technical operations support in several areas such as deployment of single-use systems in vaccine manufacturing, process improvements, technical collaborations with single-use systems’ suppliers, regulatory remediation plans, vaccines localization technology transfers, cell culture media and drug substance manufacturing. She is the recipient of the 2018 Frost & Sullivan Manufacturing Leadership Award in the Engineering and Production Technology Leadership category for the Design, Evaluation and Implementation of Single-Use Components for Ebola Zaire Vaccines Drug Substance Manufacturing, 2020 PDA Distinguished Service Award and 2020 Merck Manufacturing Science & Technology Big Innovation Award. Currently, she is the co-lead of the PDA Vaccines Interest Group and member of the PDA Biopharmaceutical Advisory Board. Prior to joining Merck, she worked at Irvine Scientific, Allergan and the Instituto Colombiano del Petróleo where she contributed to the development and manufacturing of cell culture media products, process characterization and improvement of Botox® and development of biological wastewater technologies, respectively. She holds a BS and MSc degrees in Chemical Engineering from Universidad Nacional de Colombia and PhD degree in Engineering from the University of Akron, Ohio.

  • 14:10 – 14:35

    Patient-Centric Development for Vaccines

    • Presenter: Frédéric Mathot, PhD, Associate Director, Scientific Leader, GSK

      

      Frédéric Mathot, PhD, Associate Director, Scientific Leader, GSK
      

      Dr. Frederic Mathot, Associate Director and Scientific Leader at GSK, holds a PhD in Pharmaceutical Sciences and currently works in the pharmaceutical industry for more than 15 years. His role at GSK Vaccines in R&D involves leading the Drug Product development of nucleic acid-based vaccines and other innovative technologies. His work primarily focuses on the physico-chemistry of biomolecules and drug product formulation. He is also involved in academia, supervising PhD students and lecturing at UCLouvain in Brussels, Belgium. His career includes several patents and he has been recognized with a few awards.

  • 14:35 – 15:00

    Applying Prior Knowledge and Patient Centric Based Considerations to Specification Setting

    • Presenter: Pepijn Burgers, PhD, Scientific Director Biologics AD , JnJ Innovative Medicine

      

      Pepijn Burgers, PhD, Scientific Director Biologics AD , JnJ Innovative Medicine
      

      Pepijn Burgers is a scientific director at JnJ Innovative Medicine where he leads the product characterization group within the advanced therapies realm. His group is responsible for CQA determination and helping determine the control strategy, product characterization as well as stability. Previously he worked at Merck/MSD in process development. In his spare time he loves skiing, climbing, paddle boarding (and also paddle boarding to work when it's nice out) and having fun tasting different beers with friends.

  • 15:00 – 15:30

    Q&A

    • Moderator: Cristiana Campa, PhD, Technical R&D Advisor, GSK

      

      Cristiana Campa, PhD, Technical R&D Advisor, GSK
      

      Cristiana Campa, PhD, is currently a Technical R&D Advisor at GSK Vaccines, with involvement in CMC development portfolio support and scientific advocacy, focusing on CMC strategies and innovation, with active participation in several cross-company working groups (e.g.,PDA, EFPIA/ Vaccines Europe, IFPMA). She has more than 20 years experience in biologics and related analytical and development approaches, gained in different universities and companies. She joined Novartis Vaccines in 2006, focusing on development, validation and transfer of analytical methods for release and characterization of several vaccine products, first as senior manager and then as Head of Analytical Development, Italy. Since 2012, Cristiana has worked on Quality by Design (QbD) principles implementation for vaccines. After acquisition of Novartis Vaccines by GSK in 2015, she has been the Head of QbD Integration and, until June 2018, the Head of Science and Development Practices in Technical R&D, covering QbD implementation, Knowledge Management and Development roadmaps. Since 2023, Cristiana is an elected member of the PDA Board of Directors. Since 2024, she is the co-chair of the PDA Vaccine Interest Group, and a member of the ICH Expert Working Group dedicated to ICHQ6 Guideline (Specifications) revision (EFPIA lead).

    • Panelist: Sabrina Restrepo, PhD, Director, Vaccines - Technical Product Leadership, Merck & Co., Inc.

      

      Sabrina Restrepo, PhD, Director, Vaccines - Technical Product Leadership, Merck & Co., Inc.
      

      Sabrina's responsibilities at Merck have included technical operations support in several areas such as deployment of single-use systems in vaccine manufacturing, process improvements, technical collaborations with single-use systems’ suppliers, regulatory remediation plans, vaccines localization technology transfers, cell culture media and drug substance manufacturing. She is the recipient of the 2018 Frost & Sullivan Manufacturing Leadership Award in the Engineering and Production Technology Leadership category for the Design, Evaluation and Implementation of Single-Use Components for Ebola Zaire Vaccines Drug Substance Manufacturing, 2020 PDA Distinguished Service Award and 2020 Merck Manufacturing Science & Technology Big Innovation Award. Currently, she is the co-lead of the PDA Vaccines Interest Group and member of the PDA Biopharmaceutical Advisory Board. Prior to joining Merck, she worked at Irvine Scientific, Allergan and the Instituto Colombiano del Petróleo where she contributed to the development and manufacturing of cell culture media products, process characterization and improvement of Botox® and development of biological wastewater technologies, respectively. She holds a BS and MSc degrees in Chemical Engineering from Universidad Nacional de Colombia and PhD degree in Engineering from the University of Akron, Ohio.

    • Panelist: Frédéric Mathot, PhD, Associate Director, Scientific Leader, GSK

      

      Frédéric Mathot, PhD, Associate Director, Scientific Leader, GSK
      

      Dr. Frederic Mathot, Associate Director and Scientific Leader at GSK, holds a PhD in Pharmaceutical Sciences and currently works in the pharmaceutical industry for more than 15 years. His role at GSK Vaccines in R&D involves leading the Drug Product development of nucleic acid-based vaccines and other innovative technologies. His work primarily focuses on the physico-chemistry of biomolecules and drug product formulation. He is also involved in academia, supervising PhD students and lecturing at UCLouvain in Brussels, Belgium. His career includes several patents and he has been recognized with a few awards.

    • Panelist: Pepijn Burgers, PhD, Scientific Director Biologics AD , JnJ Innovative Medicine

      

      Pepijn Burgers, PhD, Scientific Director Biologics AD , JnJ Innovative Medicine
      

      Pepijn Burgers is a scientific director at JnJ Innovative Medicine where he leads the product characterization group within the advanced therapies realm. His group is responsible for CQA determination and helping determine the control strategy, product characterization as well as stability. Previously he worked at Merck/MSD in process development. In his spare time he loves skiing, climbing, paddle boarding (and also paddle boarding to work when it's nice out) and having fun tasting different beers with friends.

• 15:30 – 16:00

  Networking Coffee Break, Poster Session & Exhibition

  Övre Verandan
• 16:00 – 17:45

  Session 2 Track A: Opportunities for Vaccine Access

  Banquet Hall 1

  • Moderator: Mic McGoldrick, Technical Advocacy and Policy - CMC, Merck Sharp & Dohme Corp. LLC

    

    Mic McGoldrick, Technical Advocacy and Policy - CMC, Merck Sharp & Dohme Corp. LLC
    

    Mic is currently a Director of CMC Technical Advocacy & Policy at Merck Sharp and Dohme, Corp. His background in the life sciences started with degrees in Microbiology, Chemistry, and Medical Technology and has experience with Vaccine and Biologics in the Pharmaceutical field for over 30 years. For 15 years Mic worked in Regulatory Affairs on INDs, new product filings, and post approval submissions globally. For a large portion of this time he led the evaluation of worldwide guidances and the expansion of vaccines into the Emerging Markets. For the last eight years Mic has been working on CMC Policy for Vaccines and Biologics, advocating for reliance, harmonization and greater access of vaccines to patients.

  This session will explore opportunities for increased access to vaccines globally. As important as vaccines are to health throughout the world, there have been barriers to access. We will explore the use of different technologies to increase the speed of development and approval. We will also look at the regulatory side impacting access. As markets and supply become more global, there is a need to have regulatory processes that approach new technologies and routine work in a more harmonized manner and to expand the use of reliance.

  Track A

  • 16:00 – 16:25

    Fast Evolving Vaccine Innovation Landscape

    • Presenter: Anna Czwarno, Ms.Eng., Regulatory, Manufacturing & Supply Director, Vaccines Europe, Vaccines Europe

      

      Anna Czwarno, Ms.Eng., Regulatory, Manufacturing & Supply Director, Vaccines Europe, Vaccines Europe
      

      Anna Czwarno, M. S.C. Eng. Anna Czwarno is a Regulatory, Manufacturing & Supply Director at Vaccines Europe, a specialised group within the European Federation of Pharmaceutical Industries and Associations (EFPIA), representing the R&D - based pharmaceutical industry in Europe. She oversees the regulatory, manufacturing and supply topics for vaccines. She joined Vaccines Europe/EFPIA in April 2016. Anna brings more than 20 years of experiences working in the pharmaceutical industry sectors (Lilly, Bayer, Novartis pharma and Novartis vaccines) as well educational. Anna, a Polish national, holds a Master’s degree from the Warsaw University of Technology, Faculty of Chemical and Process Engineering (1993) and postgraduate studies at the Warsaw University Faculty of Pedagogy.

  • 16:25 – 16:50

    Building Health Emergency Preparedness by Harnessing the Potential of Vaccine Platforms

    • Presenter: Ramin Sabet-Azad, PhD, CMC Lead, The Coalition for Epidemic Preparedness Innovations (CEPI)

      

      Ramin Sabet-Azad, PhD, CMC Lead, The Coalition for Epidemic Preparedness Innovations (CEPI)
      

      Dr. Ramin Sabet-Azad is Chemistry, Manufacturing and Controls (CMC) Lead at CEPI, London, supporting the organisation as CMC subject matter expert in CEPI’s pancoronavirus disease program, protein vaccine program and its adjuvants task force. He is also working towards consensus between industry and regulators around use of Platform technologies for rapid response to outbreaks and health threat. He has a MSc and PhD in Biochemical Engineering from Lund University, Sweden, and several years of industrial experience in manufacturing of vaccines and biochemicals. Most notably, at Bavarian Nordic he worked on the approved MVA smallpox/mpox vaccine, and subsequently led DS process development activities for Mvabea, part of Janssen’s EMA/FDA authorised vaccine regimen for protection against the Ebola Zaire virus.

  • 16:50 – 17:15

    Regulatory Global Convergence, Harmonization, and Reliance

    • Presenter: Navdip Ghai, Director - Regulatory Affairs CMC, Merck Sharpe & Dohme

      

      Navdip Ghai, Director - Regulatory Affairs CMC, Merck Sharpe & Dohme
      

      Navdip Ghai is a Regulatory CMC professional at Merck Sharp & Dohme based in the USA and leads a team supporting HPV (Human Papillomavirus) vaccines in global markets. His career spans over 23 years in Bio-pharmaceutical industry with various roles in technical operations, validation, regulatory affairs, and CMC. He has deep exposure to China regulatory environment having led initial approval and renewals of 2 HPV vaccines in China.

  • 17:15 – 17:45

    Q&A

    • Moderator: Mic McGoldrick, Technical Advocacy and Policy - CMC, Merck Sharp & Dohme Corp. LLC

      

      Mic McGoldrick, Technical Advocacy and Policy - CMC, Merck Sharp & Dohme Corp. LLC
      

      Mic is currently a Director of CMC Technical Advocacy & Policy at Merck Sharp and Dohme, Corp. His background in the life sciences started with degrees in Microbiology, Chemistry, and Medical Technology and has experience with Vaccine and Biologics in the Pharmaceutical field for over 30 years. For 15 years Mic worked in Regulatory Affairs on INDs, new product filings, and post approval submissions globally. For a large portion of this time he led the evaluation of worldwide guidances and the expansion of vaccines into the Emerging Markets. For the last eight years Mic has been working on CMC Policy for Vaccines and Biologics, advocating for reliance, harmonization and greater access of vaccines to patients.

    • Panelist: Anna Czwarno, Ms.Eng., Regulatory, Manufacturing & Supply Director, Vaccines Europe, Vaccines Europe

      

      Anna Czwarno, Ms.Eng., Regulatory, Manufacturing & Supply Director, Vaccines Europe, Vaccines Europe
      

      Anna Czwarno, M. S.C. Eng. Anna Czwarno is a Regulatory, Manufacturing & Supply Director at Vaccines Europe, a specialised group within the European Federation of Pharmaceutical Industries and Associations (EFPIA), representing the R&D - based pharmaceutical industry in Europe. She oversees the regulatory, manufacturing and supply topics for vaccines. She joined Vaccines Europe/EFPIA in April 2016. Anna brings more than 20 years of experiences working in the pharmaceutical industry sectors (Lilly, Bayer, Novartis pharma and Novartis vaccines) as well educational. Anna, a Polish national, holds a Master’s degree from the Warsaw University of Technology, Faculty of Chemical and Process Engineering (1993) and postgraduate studies at the Warsaw University Faculty of Pedagogy.

    • Panelist: Ramin Sabet-Azad, PhD, CMC Lead, The Coalition for Epidemic Preparedness Innovations (CEPI)

      

      Ramin Sabet-Azad, PhD, CMC Lead, The Coalition for Epidemic Preparedness Innovations (CEPI)
      

      Dr. Ramin Sabet-Azad is Chemistry, Manufacturing and Controls (CMC) Lead at CEPI, London, supporting the organisation as CMC subject matter expert in CEPI’s pancoronavirus disease program, protein vaccine program and its adjuvants task force. He is also working towards consensus between industry and regulators around use of Platform technologies for rapid response to outbreaks and health threat. He has a MSc and PhD in Biochemical Engineering from Lund University, Sweden, and several years of industrial experience in manufacturing of vaccines and biochemicals. Most notably, at Bavarian Nordic he worked on the approved MVA smallpox/mpox vaccine, and subsequently led DS process development activities for Mvabea, part of Janssen’s EMA/FDA authorised vaccine regimen for protection against the Ebola Zaire virus.

    • Panelist: Navdip Ghai, Director - Regulatory Affairs CMC, Merck Sharpe & Dohme

      

      Navdip Ghai, Director - Regulatory Affairs CMC, Merck Sharpe & Dohme
      

      Navdip Ghai is a Regulatory CMC professional at Merck Sharp & Dohme based in the USA and leads a team supporting HPV (Human Papillomavirus) vaccines in global markets. His career spans over 23 years in Bio-pharmaceutical industry with various roles in technical operations, validation, regulatory affairs, and CMC. He has deep exposure to China regulatory environment having led initial approval and renewals of 2 HPV vaccines in China.

• 16:00 – 17:45

  Session 2 Track B: Innovation in Biomanufacturing

  Banquet Hall 2

  • Moderator: Michael R. De Felippis, PhD, Senior Vice President - Research Bioproduct Research and Development, Eli Lilly and Company

    

    Michael R. De Felippis, PhD, Senior Vice President - Research Bioproduct Research and Development, Eli Lilly and Company
    

    Michael R. De Felippis, Ph.D. is a Senior Vice President - Research in the Bioproduct Research and Development Organization of Eli Lilly and Company. He is responsible for providing strategic scientific oversight of the CMC activities for the biopharmaceutical product portfolio with emphasis on analytical, process and product development, control strategy definition, and preparation of CMC-related regulatory documentation supporting global licensure. Professional activities external to Lilly include member of the USP Council of Experts, Chair of the USP Expert Committee on Therapeutic Peptides and Oligonucleotides, member of the European Pharmacopoeia Gene Therapy Products Working Party, and member of the EFPIA ATMP Manufacturing and GMP Sub-team.

  Grow your knowledge as experts from academia and industry share their innovative approaches to biopharmaceutical manufacturing. Beginning with upstream process operations, learn how a novel cell-free protein system can enable the production of therapeutic proteins without relying on cell culture and utilizing only DNA, buffer components, and the transcription and translation machinery extracted from cells. This synthetic strategy offers faster protein production and greater control relative to conventional cell culture processes. Moving on to the downstream process, discover how high-temperature inactivation can serve as an orthogonal tool to clear heat-susceptible contaminants. Case studies will demonstrate how heat treatment can be applied to inactivate host cell-derived enzymes to ensure product stability and as an alternative for viral inactivation. The survey of biopharmaceutical manufacturing innovation included in this session concludes with a focused discussion on polysorbate degradation. Instability of this widely used excipient in drug product formulations presents a major technical challenge for biopharmaceutical manufacturing and quality control. Recommendations are provided for designing a comprehensive control strategy to minimize risks.

  Track B

  • 16:00 – 16:25

    Cell-Free Manufacturing of Proteins

    • Presenter: Matthias Steiger, MSc, Research Scientist, Invitris GmbH

      

      Matthias Steiger, MSc, Research Scientist, Invitris GmbH
      

      Matthias Steiger is a Research Scientist at Invitris GmbH, dedicated to advancing the manufacturing of proteins and highly structured protein assemblies, such as phages, through cell-free protein synthesis (CFPS) systems. His work entails leveraging CFPS systems for protein engineering and enhancing cell-free systems themselves including scaling-up processes. Prior to joining Invitris, Matthias pursued a PhD at Prof. Volker Sieber’s lab at the Technical University Munich in collaboration with ETH Zurich. His doctoral research focused on developing a cell-free ultrahigh-throughput screening system for identifying novel enzymes from metagenomic DNA. This involved the preparation of cell extracts for cell-free protein synthesis, alongside developing appropriate assay systems.

  • 16:25 – 16:50

    Application and Utilization of Heat Inactivation as a Downstream Purification Tool in Biomanufacturing Processes

    • Presenter: Colette Carmody Culhane, MSc., Senior Advisor, Manufacturing Science and Technology, Eli Lilly & Company

      

      Colette Carmody Culhane, MSc., Senior Advisor, Manufacturing Science and Technology, Eli Lilly & Company
      

      Colette Carmody Culhane is a Senior Scientific Advisor at Eli Lilly, Kinsale. She received her BSc in chemistry from University College Cork and MSc in Biopharmaceutical Sciences from Sligo, Institute of Technology, Ireland. Colette joined Eli Lilly in 2003 and has provided various technical leadership roles within the Quality Control Laboratory (QCL) and Manufacturing Science and Technology organizations. In recent years, she has been responsible for the technical transfer and process validation of new biomanufacturing processes, along with providing technical oversight and control strategy expertise to ensure the reliable supply of Lilly's commercial medical products.

  • 16:50 – 17:15

    Polysorbate Control Strategies in Biopharmaceuticals

    • Presenter: Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG

      

      Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG
      

      Atanas Koulov has extensive experience in pharmaceutical drug product development and manufacturing from Roche/Genentech, Novartis and Lonza. His focus areas are drug product control strategies, particle contamination and quality control. He has authored more than 50 scientific publications and book chapters. He is a co-founder and Chief Scientific Officer or Clear Solutions Laboratories AG.

    • Presenter: Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG

      

      Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG
      

      Atanas Koulov has extensive experience in pharmaceutical drug product development and manufacturing from Roche/Genentech, Novartis and Lonza. His focus areas are drug product control strategies, particle contamination and quality control. He has authored more than 50 scientific publications and book chapters. He is a co-founder and Chief Scientific Officer or Clear Solutions Laboratories AG.

  • 17:15 – 17:45

    Q&A

    • Moderator: Michael R. De Felippis, PhD, Senior Vice President - Research Bioproduct Research and Development, Eli Lilly and Company

      

      Michael R. De Felippis, PhD, Senior Vice President - Research Bioproduct Research and Development, Eli Lilly and Company
      

      Michael R. De Felippis, Ph.D. is a Senior Vice President - Research in the Bioproduct Research and Development Organization of Eli Lilly and Company. He is responsible for providing strategic scientific oversight of the CMC activities for the biopharmaceutical product portfolio with emphasis on analytical, process and product development, control strategy definition, and preparation of CMC-related regulatory documentation supporting global licensure. Professional activities external to Lilly include member of the USP Council of Experts, Chair of the USP Expert Committee on Therapeutic Peptides and Oligonucleotides, member of the European Pharmacopoeia Gene Therapy Products Working Party, and member of the EFPIA ATMP Manufacturing and GMP Sub-team.

    • Panelist: Matthias Steiger, MSc, Research Scientist, Invitris GmbH

      

      Matthias Steiger, MSc, Research Scientist, Invitris GmbH
      

      Matthias Steiger is a Research Scientist at Invitris GmbH, dedicated to advancing the manufacturing of proteins and highly structured protein assemblies, such as phages, through cell-free protein synthesis (CFPS) systems. His work entails leveraging CFPS systems for protein engineering and enhancing cell-free systems themselves including scaling-up processes. Prior to joining Invitris, Matthias pursued a PhD at Prof. Volker Sieber’s lab at the Technical University Munich in collaboration with ETH Zurich. His doctoral research focused on developing a cell-free ultrahigh-throughput screening system for identifying novel enzymes from metagenomic DNA. This involved the preparation of cell extracts for cell-free protein synthesis, alongside developing appropriate assay systems.

    • Panelist: Colette Carmody Culhane, MSc., Senior Advisor, Manufacturing Science and Technology, Eli Lilly & Company

      

      Colette Carmody Culhane, MSc., Senior Advisor, Manufacturing Science and Technology, Eli Lilly & Company
      

      Colette Carmody Culhane is a Senior Scientific Advisor at Eli Lilly, Kinsale. She received her BSc in chemistry from University College Cork and MSc in Biopharmaceutical Sciences from Sligo, Institute of Technology, Ireland. Colette joined Eli Lilly in 2003 and has provided various technical leadership roles within the Quality Control Laboratory (QCL) and Manufacturing Science and Technology organizations. In recent years, she has been responsible for the technical transfer and process validation of new biomanufacturing processes, along with providing technical oversight and control strategy expertise to ensure the reliable supply of Lilly's commercial medical products.

    • Panelist: Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG

      

      Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG
      

      Atanas Koulov has extensive experience in pharmaceutical drug product development and manufacturing from Roche/Genentech, Novartis and Lonza. His focus areas are drug product control strategies, particle contamination and quality control. He has authored more than 50 scientific publications and book chapters. He is a co-founder and Chief Scientific Officer or Clear Solutions Laboratories AG.

    • Panelist: Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG

      

      Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG
      

      Atanas Koulov has extensive experience in pharmaceutical drug product development and manufacturing from Roche/Genentech, Novartis and Lonza. His focus areas are drug product control strategies, particle contamination and quality control. He has authored more than 50 scientific publications and book chapters. He is a co-founder and Chief Scientific Officer or Clear Solutions Laboratories AG.

• 18:30 – 22:00

  Networking Event

Wednesday, 25 September CEST

• 07:30 – 17:30

  Registration Open

  Övre Verandan
• 08:00 – 08:45

  Track A: Interest Group Session: Advanced Manufacturing and Applied Process Digitalization (former Biomanufacturing IG)

  Banquet Hall 1

  • Moderator: Toni Manzano, Co-Founder and CSO of Aizon, and Team Leader, AI in Operations (AIO), Aizon and United Nations, professor at the URV

    

    Toni Manzano, Co-Founder and CSO of Aizon, and Team Leader, AI in Operations (AIO), Aizon and United Nations, professor at the URV
    

    Toni is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. He is also co-chair of the CPV of the Future initiative at the PDA, PDA RAQAB member and active and he teaches AI subjects at the Universities (UAB, URV and OBS), collaborator with the United Nations in AI subjects. He has written numerous articles in the Pharma field and holds a dozen international patents related to the encryption, transmission, storage and processing of large volumes of data for regulated environments in the cloud. Toni is Physicist, Master in Information and Knowledge Society and post graduated in quality systems for manufacturing and research pharmaceutical processes.

  • Moderator: Peter J. Makowenskyj, MEng, Director of Design Consulting, G-CON

    

    Peter J. Makowenskyj, MEng, Director of Design Consulting, G-CON
    

    Peter has over 19 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various roles within industry, primarily around process solutions and engineering for drug substance facilities. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities. Peter joined G-CON Manufacturing in 2016 where he he consults with clients in the design of their cGMP facilities utilizing G-CON’s pre-fabricated autonomous clean rooms by capitalizing on his process and regulatory know how. Peter received his Bachelor of Science in Chemical Engineering and a Minor in Biomedical Engineering from Cornell University. He received his M. Eng in Chemical Engineering from Cornell University. He is also very active within the PDA where he currently sits on the PDA BioAB as vice-chair, co-Leads the Advanced Manufacturing and Applied Process Digitalization IG, and Mobile Manufacturing Task Force.

  The Advanced Manufacturing and Applied Process Digitalization IG will be providing an update on two active Task Force Initiatives underway within the PDA. The Mobile Manufacturing Task Forces currently working on a Points to Consider Paper, which is planned to be issued this year and will provide an update on the key points/questions it will address. The AI Task Force will provide an update on the roadmap it created, a summary of the gap assessment, digitalization implementation survey results, AI Glossary, and future activities. The updates will be followed by an open discussion with the IG members on current hot topics.

  Track A
• 08:00 – 08:45

  Track B: Interest Group Session: Lyophilization

  Banquet Hall 2

  • Moderator: Anthony Cannon, Director, ExM PTO Sterile , MSD International

    

    Anthony Cannon, Director, ExM PTO Sterile , MSD International
    

    Tony is currently Director, External Manufacturing Technical Operations, for SM Sterile Products at MSD located in Lucerne, Switzerland. He is responsible for technical support of Sterile Small Molucule drug products for external manufacturing operations for the SM and Antibiotics platforms. He has held various positions throughout his career in Sterile Drug Product development and manufacturing with a focus on formulation and process development of both liquid and lyophilized parenterals, final container development and optimization, medical devices and drug delivery. He has over 25 years’ in the industry with experience in biologics (plasma products, proteins, peptides, liposomes, vaccines; viral and bacterial), small molecules, nanocrystals, medical devices, reagents, nutriceuticals and cytotoxics, focused on lyophilization development and manufacturing. He has also presented on the fundamental of lyophilization, formulation, process development, thermal characterization, finished product analysis, and scale up and tech transfer at various conferences, seminars and pharmaceutical and biotech companies in North America, Europe and Asia.

  We will be focusing on Annex 1 implementation, topics such as: • PUPSIT of for the N2 filters • Operators in Grade A (managing current manual loading operations) • Campaigning batches (cleaning/sterilization between batches) • Overall Survey on actions completed to comply with Annex 1

  Track B
• 09:00 – 10:45

  Session 3 Track A: Digital Tools Shaping Future Biomanufacturing

  Banquet Hall 1

  • Moderator: Adithya Balasubramanian, MS, Director, ten23 health AG

    

    Adithya Balasubramanian, MS, Director, ten23 health AG
    

    With more than 15 years of experience in the biotech industry, including positions at Genentech, Regeneron, and Lonza, Adi is an experienced Business Development Director at ten23 health. Adi's expertise lies in external collaborations, alliance management, and pharmaceutical development, specifically in the areas of formulation development and in-use stability and compatibility. At ten23 health, Adi's primary focus is to identify new business opportunities for the company, build the ten23 brand, and provide strategic and tactical guidance to our Development teams. Adi began his career as a Research Associate at Regeneron and Genentech, where he worked on Eylea (Aflibercept), Praluent (Alirocumab), and Polivy (Polatuzumab vedotin). Adi played a pivotal role in establishing the technical operations team at ten23 health and Lonza Drug Product Services. Above all, Adi's true passion lies in creating innovative solutions that enhance patient outcomes and experiences.

  This session explores how digital tools are transforming the biomanufacturing industry by enhancing efficiency, precision, and innovation. We will delve into key topics such as the integration of AI and machine learning for predictive analytics and process optimization, the influence of regulatory agencies on industry digitization, and the acceleration of manufacturing processes through digitalization. Participants will gain insights from industry experts, discover the latest digital innovations, and learn how these tools can foster scalability, flexibility, and sustainability in biomanufacturing operations.

  Track A

  • 09:00 – 09:25

    The Key Role of AI in Biomanufacturing and Good Practices to Implement it

    • Presenter: Toni Manzano, Co-Founder and CSO of Aizon, and Team Leader, AI in Operations (AIO), Aizon and United Nations, professor at the URV

      

      Toni Manzano, Co-Founder and CSO of Aizon, and Team Leader, AI in Operations (AIO), Aizon and United Nations, professor at the URV
      

      Toni is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. He is also co-chair of the CPV of the Future initiative at the PDA, PDA RAQAB member and active and he teaches AI subjects at the Universities (UAB, URV and OBS), collaborator with the United Nations in AI subjects. He has written numerous articles in the Pharma field and holds a dozen international patents related to the encryption, transmission, storage and processing of large volumes of data for regulated environments in the cloud. Toni is Physicist, Master in Information and Knowledge Society and post graduated in quality systems for manufacturing and research pharmaceutical processes.

  • 09:25 – 09:50

    A Regulatory Framework Enabling Digital Innovation in Manufacturing

    • Presenter: Mónica Perea-Vélez, MSc, PhD, CMC Advocacy and Policy Director, GSK

      

      Mónica Perea-Vélez, MSc, PhD, CMC Advocacy and Policy Director, GSK
      

      Mónica works as Advocacy and Policy Director at GSK’s CMC Global Regulatory Affairs (GRA). She is a medical biologist by training and holds a Masters in Molecular Biology and a PhD in Bioscience Engineering. Mónica has over 17 years’ experience in the pharmaceutical sector where she has held different CMC positions within Regulatory Affairs and Quality Assurance. She has a deep expertise in vaccines product development, clinical trial applications and MAA globally. In her current role, she is responsible for leading GSK’s global LCM and China CMC advocacy and policy activities. Mónica is currently member of EFPIA, IFPMA and VE trade associations working teams with focus on LCM activities globally and in China.

  • 09:50 – 10:15

    Accelerated Process Development using End-to-End Digital Twins

    • Presenter: Thomas Zahel, PhD, Head of Innovation, Körber Pharma Austria GmbH

      

      Thomas Zahel, PhD, Head of Innovation, Körber Pharma Austria GmbH
      

      Thomas Zahel is Head of Innovation at Körber Pharma Austria GmbH, with outstanding experience in statistics, algorithm development and turning complex challenges into easy concepts for biopharmaceutical companies. His background is in bioprocess engineering and he holds a PhD in applied statistics for process development and validation. He is most passionate about developing new statistical methods and turn them into intuitive data science tools.

  • 10:15 – 10:45

    Q&A

    • Moderator: Adithya Balasubramanian, MS, Director, ten23 health AG

      

      Adithya Balasubramanian, MS, Director, ten23 health AG
      

      With more than 15 years of experience in the biotech industry, including positions at Genentech, Regeneron, and Lonza, Adi is an experienced Business Development Director at ten23 health. Adi's expertise lies in external collaborations, alliance management, and pharmaceutical development, specifically in the areas of formulation development and in-use stability and compatibility. At ten23 health, Adi's primary focus is to identify new business opportunities for the company, build the ten23 brand, and provide strategic and tactical guidance to our Development teams. Adi began his career as a Research Associate at Regeneron and Genentech, where he worked on Eylea (Aflibercept), Praluent (Alirocumab), and Polivy (Polatuzumab vedotin). Adi played a pivotal role in establishing the technical operations team at ten23 health and Lonza Drug Product Services. Above all, Adi's true passion lies in creating innovative solutions that enhance patient outcomes and experiences.

    • Panelist: Toni Manzano, Co-Founder and CSO of Aizon, and Team Leader, AI in Operations (AIO), Aizon and United Nations, professor at the URV

      

      Toni Manzano, Co-Founder and CSO of Aizon, and Team Leader, AI in Operations (AIO), Aizon and United Nations, professor at the URV
      

      Toni is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. He is also co-chair of the CPV of the Future initiative at the PDA, PDA RAQAB member and active and he teaches AI subjects at the Universities (UAB, URV and OBS), collaborator with the United Nations in AI subjects. He has written numerous articles in the Pharma field and holds a dozen international patents related to the encryption, transmission, storage and processing of large volumes of data for regulated environments in the cloud. Toni is Physicist, Master in Information and Knowledge Society and post graduated in quality systems for manufacturing and research pharmaceutical processes.

    • Panelist: Mónica Perea-Vélez, MSc, PhD, CMC Advocacy and Policy Director, GSK

      

      Mónica Perea-Vélez, MSc, PhD, CMC Advocacy and Policy Director, GSK
      

      Mónica works as Advocacy and Policy Director at GSK’s CMC Global Regulatory Affairs (GRA). She is a medical biologist by training and holds a Masters in Molecular Biology and a PhD in Bioscience Engineering. Mónica has over 17 years’ experience in the pharmaceutical sector where she has held different CMC positions within Regulatory Affairs and Quality Assurance. She has a deep expertise in vaccines product development, clinical trial applications and MAA globally. In her current role, she is responsible for leading GSK’s global LCM and China CMC advocacy and policy activities. Mónica is currently member of EFPIA, IFPMA and VE trade associations working teams with focus on LCM activities globally and in China.

    • Panelist: Thomas Zahel, PhD, Head of Innovation, Körber Pharma Austria GmbH

      

      Thomas Zahel, PhD, Head of Innovation, Körber Pharma Austria GmbH
      

      Thomas Zahel is Head of Innovation at Körber Pharma Austria GmbH, with outstanding experience in statistics, algorithm development and turning complex challenges into easy concepts for biopharmaceutical companies. His background is in bioprocess engineering and he holds a PhD in applied statistics for process development and validation. He is most passionate about developing new statistical methods and turn them into intuitive data science tools.

• 09:00 – 10:45

  Session 3 Track B: Future Techniques in Freeze-Drying

  Banquet Hall 2

  • Moderator: Sebastian Groel, PhD, Manager Formulation Technology, Daiichi Sankyo Europe

    

    Sebastian Groel, PhD, Manager Formulation Technology, Daiichi Sankyo Europe
    

    Dr. Sebastian Groel is a pharmacist by training with expertise in freeze-drying and solid-state analysis of amorphous substances. Since 2024, he is working on process development at Daiichi Sankyo Europe as Formulation Technology Manager. Before joining Daiichi Sankyo, he spent a year as a postdoctoral researcher at Boehringer Ingelheim. Dr. Groel completed his PhD at the LMU Munich under the supervision of Prof. Dr. Gerhard Winter, where he successfully investigated and published several papers on freeze-drying and calorimetric investigation of relaxation phenomena in the solid-state.

  Step into the future of biomanufacturing with our second session on freeze-drying and lyophilization processes, highlighting the future techniques and technological breakthroughs in the machinery as well as process design. Discover how an innovative air-cooling technology offers a reduced global warming potential and ensures high production reliability. Explore a pioneering continuous lyophilization technique for mRNA-lipid nanoparticles that enhances long-term stability and maintains product integrity even after extended storage at room temperature. Gain valuable insights into the thermal interactions during biopharmaceutical freezing, focusing on how vial arrangement impacts nucleation temperature distribution and overall product quality. Remain at the recent technology of industry developments and deepen your expertise in freeze-drying technology.

  Track B

  • 09:00 – 09:25

    Sustainable Refrigeration Technologies: Overview and Implementation of Innovative Air-Cooling Technology for Freeze-Drying Processes

    • Co-Presenter: Fabian Plaum, M.Eng., Sales Management, HOF Sonderanlagenbau GmbH

      

      Fabian Plaum, M.Eng., Sales Management, HOF Sonderanlagenbau GmbH
      

      Fabian Plaum is working in the Sales Management for Freeze-Drying and Freeze-Thaw applications at HOF Sonderanlagenbau GmbH. In 2014 he started his studies for mechanical engineering at HOF and has successfully completed these studies with a Master of Engineering. Additionally, since 2014 he has worked in different areas at HOF, as Mechanical Engineering, Project Management and since 2019 within the sales department at HOF. Within the Sales Management Fabian is responsible for the customer care and the creation of customized concepts for the integration of Freeze-Thaw equipment and Freeze-Dryers into aseptic fill and finish lines.

    • Co-Presenter: Christian Sonntag, MS, Senior Project Manager, Roche Diagnostics GmbH

      

      Christian Sonntag, MS, Senior Project Manager, Roche Diagnostics GmbH
      

      Christian Sonntag Education: 2003 - 2007: University of Applied Sciences, Dresden (Production Technology, Dipl.Ing.) --> 2005: Northern Airzona University, Flagstaff (exchange semester) 2007 - 2008: University of Tennessee, Knoxville (Industrial Engineering, Master of Science) --> Fulbright scholarship Work Experience: 2009 - 2012: Haupt Pharma Wolfratshausen (Assistant of Managing Director) 2012 - 2016: Haupt Pharma Wolfratshausen (Technical Project Manager) 2016 - 2020: Roche Diagnostics GmbH, Penzberg (Process Engineer) since 2020: Roche Diagnostics GmbH, Penzberg (Project Manager CAPEX)

  • 09:25 – 09:50

    Continuous and Controlled Lyophilization of mRNA-LNPs Based Formulations

    • Academic Presenter: Thomas De Beer, PhD, Professor, Ghent University

      

      Thomas De Beer, PhD, Professor, Ghent University
      

      Thomas De Beer graduated in pharmaceutical sciences in 2002 at the Ghent University in Belgium. He obtained his PhD at the same university in 2007. For his PhD research, he examined the suitability of Raman spectroscopy as a Process Analytical Technology tool for pharmaceutical production processes. Within his PhD research period, he worked four months at University of Copenhagen in Denmark. After his PhD, he was an FWO funded post-doctoral fellow at the Ghent University (2007-2010). Within his post-doc mandate, he worked 9 months at the Ludwig-Maximilians-University in Munich, Germany. In February 2010, he became professor in Process Analytics & Technology at the Faculty of Pharmaceutical Sciences from the university of Ghent. His research goals include bringing innovation pharmaceutical production processes (freeze-drying, hot-melt extrusion, continuous from-powder-to-tablet processing etc.). More specifically, Prof. De Beer contributes to the development of continuous manufacturing processes for drug products such as solids, semi-solids, liquids and biologicals. Thomas De Beer is also director of Ghent University’s Center of Excellence in Sustainable Pharmaceutical Engineering (CESPE) which is founded in 2016. In 2018, Thomas De Beer became co-founder and CEO of the Ghent University spin-off company RheaVita which provides a continuous freeze-drying technology for the pharmaceutical market.

  • 09:50 – 10:15

    Understanding Thermal Interactions in Biopharmaceutical Freezing: Implications for Nucleation Temperature Distribution

    • Academic Presenter: Roberto Pisano, PhD, Full Professor, Politecnico di Torino

      

      Roberto Pisano, PhD, Full Professor, Politecnico di Torino
      

      Roberto Pisano is a Full Professor of Chemical Engineering at Politecnico di Torino (Italy) where is also serving as the Coordinator of the PhD programme in chemical engineering. His research focuses on the application of both computational and experimental methods to engineering chemical products and processes, with particular emphasis on pharmaceutical processing and formulation of both small molecules and biologics, primarily lyophilized formulations. He has been visiting researcher at Centre de Ressources Technologiques – Institut Technique Agro-Industriel (Strasbourg, France) in 2008, and at the Department of Chemical Engineering of Massachusetts Institute of Technology (Cambridge, USA) in 2016. He has published 130+ papers, 14 book chapters, 1 edited book on freeze-drying of pharmaceuticals, and, currently, has 5 patents issued or pending.

  • 10:15 – 10:45

    Q&A

    • Moderator: Sebastian Groel, PhD, Manager Formulation Technology, Daiichi Sankyo Europe

      

      Sebastian Groel, PhD, Manager Formulation Technology, Daiichi Sankyo Europe
      

      Dr. Sebastian Groel is a pharmacist by training with expertise in freeze-drying and solid-state analysis of amorphous substances. Since 2024, he is working on process development at Daiichi Sankyo Europe as Formulation Technology Manager. Before joining Daiichi Sankyo, he spent a year as a postdoctoral researcher at Boehringer Ingelheim. Dr. Groel completed his PhD at the LMU Munich under the supervision of Prof. Dr. Gerhard Winter, where he successfully investigated and published several papers on freeze-drying and calorimetric investigation of relaxation phenomena in the solid-state.

    • Panelist: Fabian Plaum, M.Eng., Sales Management, HOF Sonderanlagenbau GmbH

      

      Fabian Plaum, M.Eng., Sales Management, HOF Sonderanlagenbau GmbH
      

      Fabian Plaum is working in the Sales Management for Freeze-Drying and Freeze-Thaw applications at HOF Sonderanlagenbau GmbH. In 2014 he started his studies for mechanical engineering at HOF and has successfully completed these studies with a Master of Engineering. Additionally, since 2014 he has worked in different areas at HOF, as Mechanical Engineering, Project Management and since 2019 within the sales department at HOF. Within the Sales Management Fabian is responsible for the customer care and the creation of customized concepts for the integration of Freeze-Thaw equipment and Freeze-Dryers into aseptic fill and finish lines.

    • Panelist: Christian Sonntag, MS, Senior Project Manager, Roche Diagnostics GmbH

      

      Christian Sonntag, MS, Senior Project Manager, Roche Diagnostics GmbH
      

      Christian Sonntag Education: 2003 - 2007: University of Applied Sciences, Dresden (Production Technology, Dipl.Ing.) --> 2005: Northern Airzona University, Flagstaff (exchange semester) 2007 - 2008: University of Tennessee, Knoxville (Industrial Engineering, Master of Science) --> Fulbright scholarship Work Experience: 2009 - 2012: Haupt Pharma Wolfratshausen (Assistant of Managing Director) 2012 - 2016: Haupt Pharma Wolfratshausen (Technical Project Manager) 2016 - 2020: Roche Diagnostics GmbH, Penzberg (Process Engineer) since 2020: Roche Diagnostics GmbH, Penzberg (Project Manager CAPEX)

    • Academic Panelist: Thomas De Beer, PhD, Professor, Ghent University

      

      Thomas De Beer, PhD, Professor, Ghent University
      

      Thomas De Beer graduated in pharmaceutical sciences in 2002 at the Ghent University in Belgium. He obtained his PhD at the same university in 2007. For his PhD research, he examined the suitability of Raman spectroscopy as a Process Analytical Technology tool for pharmaceutical production processes. Within his PhD research period, he worked four months at University of Copenhagen in Denmark. After his PhD, he was an FWO funded post-doctoral fellow at the Ghent University (2007-2010). Within his post-doc mandate, he worked 9 months at the Ludwig-Maximilians-University in Munich, Germany. In February 2010, he became professor in Process Analytics & Technology at the Faculty of Pharmaceutical Sciences from the university of Ghent. His research goals include bringing innovation pharmaceutical production processes (freeze-drying, hot-melt extrusion, continuous from-powder-to-tablet processing etc.). More specifically, Prof. De Beer contributes to the development of continuous manufacturing processes for drug products such as solids, semi-solids, liquids and biologicals. Thomas De Beer is also director of Ghent University’s Center of Excellence in Sustainable Pharmaceutical Engineering (CESPE) which is founded in 2016. In 2018, Thomas De Beer became co-founder and CEO of the Ghent University spin-off company RheaVita which provides a continuous freeze-drying technology for the pharmaceutical market.

    • Academic Panelist: Roberto Pisano, PhD, Full Professor, Politecnico di Torino

      

      Roberto Pisano, PhD, Full Professor, Politecnico di Torino
      

      Roberto Pisano is a Full Professor of Chemical Engineering at Politecnico di Torino (Italy) where is also serving as the Coordinator of the PhD programme in chemical engineering. His research focuses on the application of both computational and experimental methods to engineering chemical products and processes, with particular emphasis on pharmaceutical processing and formulation of both small molecules and biologics, primarily lyophilized formulations. He has been visiting researcher at Centre de Ressources Technologiques – Institut Technique Agro-Industriel (Strasbourg, France) in 2008, and at the Department of Chemical Engineering of Massachusetts Institute of Technology (Cambridge, USA) in 2016. He has published 130+ papers, 14 book chapters, 1 edited book on freeze-drying of pharmaceuticals, and, currently, has 5 patents issued or pending.

• 10:45 – 11:15

  Networking Coffee Break, Poster Session & Exhibition

  Övre Verandan
• 11:15 – 12:45

  Session 4 Track A: Fill & Finish Processing

  Banquet Hall 1

  • Moderator: Yves Mayeresse, Director, GSK

    

    Yves Mayeresse, Director, GSK
    

    Yves Mayeresse is director in manufacturing technology inside MSAT by GSK. He has more than thirty years of experience in the pharmaceutical and vaccine sector, he has worked for different companies. Yves has managed activities such as parenteral production, set-up of new Freeze-Drying facilities, design of Freeze-Drying cycle and development of new stabilizers for freeze-dried products. Transfer of product towards different internal and external site. He has worked on the industrialization of new freeze-dried products and then in the technical life cycle management. Now, Yves is focusing on different new and established technologies used for the upstream and downstream of primary operations, isolator technology and secondary operations from formulation to freeze-drying. He is an engineer in biochemistry, has written articles about Freeze-Drying science and is a regular speaker for conferences on Freeze-Drying. He is a regular committee member for PDA and former chairman of conference.

  Extractible and leachable studies can represent an important budget over the year and as soon there’s a change the process should be revalidated. With the help of a mathematical model, there’s now a way to predict the outcome without testing for some change. The tubing can equally have an uptake of VHP leading to oxidation of the active pharmaceutical ingredient, the second presentation goes through a deep analysis of this phenomenon. The last subject will deal with process modeling and how to create consistent computer-generated documentation for fill finish.

  Track A

  • 11:15 – 11:35

    Discovering Equivalence in Extractables & Leachables Assessments of Single-Use Systems: An Advanced Mathematical Methodology

    • Presenter: Armin Hauk, PhD, Principal Scientist, Sartorius Biotech GmbH

      

      Armin Hauk, PhD, Principal Scientist, Sartorius Biotech GmbH
      

      After his PhD, Armin Hauk started his professional life in 1995 as analytical scientist in the R&D department of the former Ciba-Geigy in Basle (CH). During his time at Ciba, he was head of a organic trace-analysis lab, GLP & GMP analytics, responsible for impurity profiling, migration studies, E&L investigations, development of GMP QC methods and stability testing. After 2010 he worked as consultant and Qualified Person (QP) for Intertek C&P (CH). Since 2016 he has a position at Sartorius Stedim Biotech as Principal Scientist. Armin is lecturer and trainer in E&L conferences and seminars, and he is member in various industry consortia (BPSA, BPOG, DECHEMA, MIT BioMan) Armin is one of the German delegates in the Pharmacopeia expert group 16 of the European Directorate for the Quality of Medicine (EDQM).

  • 11:35 – 11:55

    VHP Uptake of Manufacturing Tubing Used for Aseptic Fill-Finish Processes of Biopharmaceutical Drug Products

    • Presenter: Dilara Ali, MA, PhD Student , ten23 health

      

      Dilara Ali, MA, PhD Student , ten23 health
      

      Dilara Ali is a Ph.D. Student in the packaging and manufacturing group at ten23 health, a CDMO founded in 2021 in Basel, Switzerland. She holds a BSc and MSc degree in Life Sciences, Pharmaceutics, from the University of Applied Sciences and Arts Northwestern Switzerland, and is currently enrolled in a PhD program at the University of Freiburg. During her masters, alongside her studies, she worked on the development of liquid formulations. Her master's thesis investigated single-use material used during aseptic manufacturing. Currently pursuing her Ph.D., she focuses on optimizing disposable manufacturing material in fill-finish operations.

  • 11:55 – 12:15

    Frame-by-Frame - End-to-End: How Advanced Risk Profiling Accelerated the Development of a Robust Manufacturing Setup for a Brand New Kindeva Fill-Finish Site

    • Co-Presenter: Sebastian Scheler, MSc, Managing Director and Chief Methodologist, Innerspace GmbH

      

      Sebastian Scheler, MSc, Managing Director and Chief Methodologist, Innerspace GmbH
      

      Co-Founder Innerspace | Managing Director | Chief Methodologist | Frame-by-Frame Risk Profiling Supervisor I am dedicated to advancing risk assessment technologies, aiming to improve the design and management of manufacturing processes in the pharmaceutical industry. As the leader of a dynamic team comprising life science professionals and software developers, I focus on innovative AI-solutions that drive efficiency, compliance, and safety. My professional expertise centers on Frame-by-Frame Risk Profiling—an automated approach to risk assessment that enhances process improvement, automation, autogenerated SOPs, and immersive training programs. This cutting-edge technology empowers organizations to achieve unprecedented levels of operational excellence. With a strong foundation in psychology, I am deeply interested in the intersection of human behavior and technology. My passion for Virtual Reality (VR) has led to the development of pioneering VR simulator methodologies that advance experiential learning, training, and behavior measurement systems. In addition to my leadership role at Innerspace, I also serve as a trainer for PDA training courses and contribute to the ongoing development of the PDA/Innerspace partnership. This collaboration focuses on refining the delivery and design of training courses to meet the evolving needs of the industry.

    • Co-Presenter: Jeff Gensler, MBA, Vice President of Quality, Kindeva Drug Delivery

      

      Jeff Gensler, MBA, Vice President of Quality, Kindeva Drug Delivery
      

      Jeff is currently Vice President of Quality for Kindeva Drug Delivery (Kindeva). He has more than 30 years of quality leadership in the medical device and combination device industries. In addition, he has experience leading large-scale remediation efforts with a proven track record of successfully leading FDA inspections. Jeff has a depth of knowledge working with FDA and Class I, II, and III medical devices, as well as pharmaceutical and combination products. Prior to joining Kindeva, Jeff held several leadership positions, including vice president of quality assurance and quality control at Zimmer Biomet, in Indiana. Before that, he served as director of quality assurance and regulatory affairs at Dentsply International, in Pennsylvania. Jeff joined Kindeva in 2019 as the site quality operations lead, responsible for all site quality functions. As vice president of quality, he is responsible for ensuring regulatory compliance across the entire Kindeva organization. Jeff earned a B.S. in business administration and strategic management, as well as an MBA with a concentration in quality management from Upper Iowa University. He has also completed Six Sigma Greenbelt certification.

  • 12:15 – 12:45

    Q&A

    • Moderator: Yves Mayeresse, Director, GSK

      

      Yves Mayeresse, Director, GSK
      

      Yves Mayeresse is director in manufacturing technology inside MSAT by GSK. He has more than thirty years of experience in the pharmaceutical and vaccine sector, he has worked for different companies. Yves has managed activities such as parenteral production, set-up of new Freeze-Drying facilities, design of Freeze-Drying cycle and development of new stabilizers for freeze-dried products. Transfer of product towards different internal and external site. He has worked on the industrialization of new freeze-dried products and then in the technical life cycle management. Now, Yves is focusing on different new and established technologies used for the upstream and downstream of primary operations, isolator technology and secondary operations from formulation to freeze-drying. He is an engineer in biochemistry, has written articles about Freeze-Drying science and is a regular speaker for conferences on Freeze-Drying. He is a regular committee member for PDA and former chairman of conference.

    • Panelist: Dilara Ali, MA, PhD Student , ten23 health

      

      Dilara Ali, MA, PhD Student , ten23 health
      

      Dilara Ali is a Ph.D. Student in the packaging and manufacturing group at ten23 health, a CDMO founded in 2021 in Basel, Switzerland. She holds a BSc and MSc degree in Life Sciences, Pharmaceutics, from the University of Applied Sciences and Arts Northwestern Switzerland, and is currently enrolled in a PhD program at the University of Freiburg. During her masters, alongside her studies, she worked on the development of liquid formulations. Her master's thesis investigated single-use material used during aseptic manufacturing. Currently pursuing her Ph.D., she focuses on optimizing disposable manufacturing material in fill-finish operations.

    • Panelist: Sebastian Scheler, MSc, Managing Director and Chief Methodologist, Innerspace GmbH

      

      Sebastian Scheler, MSc, Managing Director and Chief Methodologist, Innerspace GmbH
      

      Co-Founder Innerspace | Managing Director | Chief Methodologist | Frame-by-Frame Risk Profiling Supervisor I am dedicated to advancing risk assessment technologies, aiming to improve the design and management of manufacturing processes in the pharmaceutical industry. As the leader of a dynamic team comprising life science professionals and software developers, I focus on innovative AI-solutions that drive efficiency, compliance, and safety. My professional expertise centers on Frame-by-Frame Risk Profiling—an automated approach to risk assessment that enhances process improvement, automation, autogenerated SOPs, and immersive training programs. This cutting-edge technology empowers organizations to achieve unprecedented levels of operational excellence. With a strong foundation in psychology, I am deeply interested in the intersection of human behavior and technology. My passion for Virtual Reality (VR) has led to the development of pioneering VR simulator methodologies that advance experiential learning, training, and behavior measurement systems. In addition to my leadership role at Innerspace, I also serve as a trainer for PDA training courses and contribute to the ongoing development of the PDA/Innerspace partnership. This collaboration focuses on refining the delivery and design of training courses to meet the evolving needs of the industry.

    • Panelist: Jeff Gensler, MBA, Vice President of Quality, Kindeva Drug Delivery

      

      Jeff Gensler, MBA, Vice President of Quality, Kindeva Drug Delivery
      

      Jeff is currently Vice President of Quality for Kindeva Drug Delivery (Kindeva). He has more than 30 years of quality leadership in the medical device and combination device industries. In addition, he has experience leading large-scale remediation efforts with a proven track record of successfully leading FDA inspections. Jeff has a depth of knowledge working with FDA and Class I, II, and III medical devices, as well as pharmaceutical and combination products. Prior to joining Kindeva, Jeff held several leadership positions, including vice president of quality assurance and quality control at Zimmer Biomet, in Indiana. Before that, he served as director of quality assurance and regulatory affairs at Dentsply International, in Pennsylvania. Jeff joined Kindeva in 2019 as the site quality operations lead, responsible for all site quality functions. As vice president of quality, he is responsible for ensuring regulatory compliance across the entire Kindeva organization. Jeff earned a B.S. in business administration and strategic management, as well as an MBA with a concentration in quality management from Upper Iowa University. He has also completed Six Sigma Greenbelt certification.

    • Panelist: Armin Hauk, PhD, Principal Scientist, Sartorius Biotech GmbH

      

      Armin Hauk, PhD, Principal Scientist, Sartorius Biotech GmbH
      

      After his PhD, Armin Hauk started his professional life in 1995 as analytical scientist in the R&D department of the former Ciba-Geigy in Basle (CH). During his time at Ciba, he was head of a organic trace-analysis lab, GLP & GMP analytics, responsible for impurity profiling, migration studies, E&L investigations, development of GMP QC methods and stability testing. After 2010 he worked as consultant and Qualified Person (QP) for Intertek C&P (CH). Since 2016 he has a position at Sartorius Stedim Biotech as Principal Scientist. Armin is lecturer and trainer in E&L conferences and seminars, and he is member in various industry consortia (BPSA, BPOG, DECHEMA, MIT BioMan) Armin is one of the German delegates in the Pharmacopeia expert group 16 of the European Directorate for the Quality of Medicine (EDQM).

• 11:15 – 12:45

  Session 4 Track B: Sustainability

  Banquet Hall 2

  • Moderator: Virginie Le Coent, Head of Scientific Affairs, EMEA Pharma QC, bioMérieux

    

    Virginie Le Coent, Head of Scientific Affairs, EMEA Pharma QC, bioMérieux
    

  Enhancing sustainability is an increasingly central concern in the biomanufacturing sector. In this session, experts from industry and EDQM will discuss sustainability initiatives to shape the future of biomanufacturing. We will hear the regulatory perspective on the integration of the 3Rs principles of Replacement, Reduction, and Refinement of animal testing in European Pharmacopoeia texts to promote and protect human and animal health. Through real-life examples, we will illustrate how companies have successfully improved their ESG (Environmental, social, and governance) scores and what benefits they can bring. Finally, consideration and implementation of sustainable water management plans to Recycle, Reuse, Reduce, and Re-purpose water in biomanufacturing will be explored as well as the need for greater collaboration between all stakeholders.

  Track B

  • 11:15 – 11:35

    Sustainability at the EDQM: A Focus on the Ph. Eur. and the 3Rs

    • Regulatory Presenter: Emmanuelle F. Charton, Head of Division B, European Pharmacopoeia Department, EDQM

      

      Emmanuelle F. Charton, Head of Division B, European Pharmacopoeia Department, EDQM
      

      Emmanuelle CHARTON holds a PhD in biochemistry from the Institut National Agronomique de Paris-Grignon. Since 2006 she is Head of Division B in the European Pharmacopoeia department at the European Directorate for the Quality of Medicines and HealthCare (EDQM). The Scientific Secretariat for the elaboration of European Pharmacopoeia texts related to microbiology fall under the responsibility of her division. Her work experience includes QA/QC in a facility for the production of parenteral products and preparation to GMP inspections in a global pharmaceutical company, research and development in biochemistry in a global company selling food and chemicals. She has over 25 years’ experience at the EDQM, including as scientific administrator to the groups of experts in the fields of biology and microbiology and as a supervisor to the corresponding work in the EDQM laboratory.

  • 11:35 – 11:55

    Enhancing Sustainability ESG Scores in BioManufacturing

    • Presenter: Philippe Gadal, PharmD Ph.D, Regulatory Intelligence Advisor, bioMerieux

      

      Philippe Gadal, PharmD Ph.D, Regulatory Intelligence Advisor, bioMerieux
      

      Dr Philippe Gadal is since 2020 serving as Regulatory Intelligence Advisor for several companies including bioMérieux, liaising with all major Pharmacopeia and National authorities in the world. Previously Dr Gadal worked, as General Manager for Hyglos in Germany. He was CEO for AES Chemunex Inc , CEO at Trinity Biotech USA and General Manager for Diagnostica Stago in the USA. Dr. Gadal participates to Microbiology Webinar Series where he speaks with microbiology experts on topics important to the industry. Dr Gadal has over 20 years of experience working with international pharmaceutical, biotechnology and diagnostics companies. Dr Gadal holds a Doctorate in Pharmacy from Toulouse University in France.

  • 11:55 – 12:15

    Using Sustainable Taxonomy: Recycle, Reuse, Reduce & Re-purpose Water for pharmaceutical Use

    • Presenter: Durga Prasad Madhavapeddi, Sr.Engineer Validation (Strategic Projects), FUJIFILM DIOSYNTH BIOTECHNOLOGIES

      

      Durga Prasad Madhavapeddi, Sr.Engineer Validation (Strategic Projects), FUJIFILM DIOSYNTH BIOTECHNOLOGIES
      

      Durga Prasad is currently working as a Sr. Engineer, Validation in Fujfilm Diosynth Biotechnologies, Denmark. He holds a master’s degree in Biochemical engineering and a certified Project Management Professional with 25 years’ experience in Pharmaceutical & Biotech industries. He started his career in India, migrated to Europe and served in roles as a Aseptic process specialist, Sterilization expert and as a consulting bioprocess engineer. His professional expertise includes Process validation, equipment qualification, sustainability, technology transfer, cross contamination mitigation, segregation concepts, large scale manufacturing of biologics & fill finish. He is a member volunteer in BioAB, Parenteral Drug Association.

  • 12:15 – 12:45

    Q&A

    • Moderator: Virginie Le Coent, Head of Scientific Affairs, EMEA Pharma QC, bioMérieux

      

      Virginie Le Coent, Head of Scientific Affairs, EMEA Pharma QC, bioMérieux
      

    • Regulatory Panelist: Emmanuelle F. Charton, Head of Division B, European Pharmacopoeia Department, EDQM

      

      Emmanuelle F. Charton, Head of Division B, European Pharmacopoeia Department, EDQM
      

      Emmanuelle CHARTON holds a PhD in biochemistry from the Institut National Agronomique de Paris-Grignon. Since 2006 she is Head of Division B in the European Pharmacopoeia department at the European Directorate for the Quality of Medicines and HealthCare (EDQM). The Scientific Secretariat for the elaboration of European Pharmacopoeia texts related to microbiology fall under the responsibility of her division. Her work experience includes QA/QC in a facility for the production of parenteral products and preparation to GMP inspections in a global pharmaceutical company, research and development in biochemistry in a global company selling food and chemicals. She has over 25 years’ experience at the EDQM, including as scientific administrator to the groups of experts in the fields of biology and microbiology and as a supervisor to the corresponding work in the EDQM laboratory.

    • Panelist: Philippe Gadal, PharmD Ph.D, Regulatory Intelligence Advisor, bioMerieux

      

      Philippe Gadal, PharmD Ph.D, Regulatory Intelligence Advisor, bioMerieux
      

      Dr Philippe Gadal is since 2020 serving as Regulatory Intelligence Advisor for several companies including bioMérieux, liaising with all major Pharmacopeia and National authorities in the world. Previously Dr Gadal worked, as General Manager for Hyglos in Germany. He was CEO for AES Chemunex Inc , CEO at Trinity Biotech USA and General Manager for Diagnostica Stago in the USA. Dr. Gadal participates to Microbiology Webinar Series where he speaks with microbiology experts on topics important to the industry. Dr Gadal has over 20 years of experience working with international pharmaceutical, biotechnology and diagnostics companies. Dr Gadal holds a Doctorate in Pharmacy from Toulouse University in France.

    • Panelist: Durga Prasad Madhavapeddi, Sr.Engineer Validation (Strategic Projects), FUJIFILM DIOSYNTH BIOTECHNOLOGIES

      

      Durga Prasad Madhavapeddi, Sr.Engineer Validation (Strategic Projects), FUJIFILM DIOSYNTH BIOTECHNOLOGIES
      

      Durga Prasad is currently working as a Sr. Engineer, Validation in Fujfilm Diosynth Biotechnologies, Denmark. He holds a master’s degree in Biochemical engineering and a certified Project Management Professional with 25 years’ experience in Pharmaceutical & Biotech industries. He started his career in India, migrated to Europe and served in roles as a Aseptic process specialist, Sterilization expert and as a consulting bioprocess engineer. His professional expertise includes Process validation, equipment qualification, sustainability, technology transfer, cross contamination mitigation, segregation concepts, large scale manufacturing of biologics & fill finish. He is a member volunteer in BioAB, Parenteral Drug Association.

• 12:45 – 13:45

  Networking Lunch Break, Poster Session & Exhibition

  Övre Verandan
• 13:45 – 13:55

  Interactive Questionnaire

  Banquet Hall 1

  • Moderator: Sabine Hauck, Dr, Consultant, _

    

    Sabine Hauck, Dr, Consultant, _
    

    Sabine Hauck has 20+ years of experience in the biotech industry, in which she held various positions in pharmaceutical development, quality assurance and regulatory affairs. Her experience spans from small molecules to cell therapies and includes a variety of dosage forms.Currently, Sabine is a freelance consultant for biopharma product development and is CTO of Thermosome.
• 13:55 – 14:45

  Closing Plenary Part I: Innovative Regulatory Strategies for a Globalized World

  Banquet Hall 1

  • Moderator: Sabine Hauck, Dr, Consultant, _

    

    Sabine Hauck, Dr, Consultant, _
    

    Sabine Hauck has 20+ years of experience in the biotech industry, in which she held various positions in pharmaceutical development, quality assurance and regulatory affairs. Her experience spans from small molecules to cell therapies and includes a variety of dosage forms.Currently, Sabine is a freelance consultant for biopharma product development and is CTO of Thermosome.

  Biopharma is an innovative field with products often developed for a global market. The last years have brought several innovative concepts to improve efficiency in the global technical and regulatory environment that we will present and discuss. Regarding manufacturing effectiveness, you will get information on upcoming guidance in the US related to Advanced Manufacturing and Continuous Manufacturing. Regarding regulatory effectiveness, ICH Q12 on post-approval changes is now in its fifth year. We will reflect on its potential to improve lifecycle management efficiency and harmonization across Regulatory Agencies. Another opportunity initiative from the industry to support harmonization and smoothen the submission pathway is Accumulus Synergy. This non-profit corporation intends to support interactions between industry and health authorities worldwide to enable real-time collaboration, data exchange, and data submission. A pilot study that shares experience from using this platform in simultaneous submission to multiple Health Authorities will be presented. After the talks, the speakers, coming from industry, research organizations, and regulatory agencies, will be available for your questions in a final panel discussion, which will also cover any final questions and reflection on the whole conference.

  • 13:55 – 14:20

    Updates on New FDA Guidance Initiatives: Platform and Advanced Manufacturing Technologies Designation Programs

    • Regulatory Presenter: Robin Levis, PhD, Deputy Director, Division of Viral Products, OVRR, CBER, U.S. FDA

      

      Robin Levis, PhD, Deputy Director, Division of Viral Products, OVRR, CBER, U.S. FDA
      

      Dr. Robin Levis has worked at the US Food and Drug Administration since 1995. She is currently the Deputy Director of the Division of Viral Products in the Office of Vaccines Research and Review at CBER/FDA. Prior to this position, she served as the Regulatory Coordinator for the Division of Viral Products and as a Senior Staff Fellow in the Laboratory of Vector Borne Viral Diseases. In addition to her work in the Office of Vaccines at CBER, she has served as the CBER representative to ICCVAM, as an observer to EDQM Group 15 for vaccines, a member of the WHO/NC3Rs working group, and serves on several vaccine working groups for the Coalition for Epidemic Preparedness Innovations. Her role on these International working groups is to encourage global regulatory harmonization and to provide regulatory support related to CMC development and product quality for viral vaccines and to the development of alternative, non-animal-based quality assays.

  • 14:20 – 14:45

    Efficiency in Pharmaceutical Life-Cycle Management: Implementing ICH Q12 and Established Conditions

    • Presenter: Thomas Stangler, PhD, Regulatory CMC Director, Sandoz

      

      Thomas Stangler, PhD, Regulatory CMC Director, Sandoz
      

      Thomas is a Regulatory CMC Director at Sandoz with 15 years of experience in developing Biosimilars for Sandoz and innovative medicines for Novartis. He holds an M.Sc. in physics and a PhD in biochemistry. He is interested in enhanced/QbD approaches to the development of Biologics and the implementation of the corresponding ICH guidances. After ICH Q8, Q9, and Q11, ICH Q12 is for him the next logical step in ensuring product quality throughout the pharmaceutical lifecycle.

• 14:45 – 15:15

  Networking Coffee Break, Poster Session & Exhibition

  Övre Verandan
• 15:15 – 15:20

  Passport Raffle

  Banquet Hall 1
• 15:20 – 16:30

  Closing Plenary Part II: Innovative Regulatory Strategies for a Globalized World

  Banquet Hall 1

  • Moderator: Sabine Hauck, Dr, Consultant, _

    

    Sabine Hauck, Dr, Consultant, _
    

    Sabine Hauck has 20+ years of experience in the biotech industry, in which she held various positions in pharmaceutical development, quality assurance and regulatory affairs. Her experience spans from small molecules to cell therapies and includes a variety of dosage forms.Currently, Sabine is a freelance consultant for biopharma product development and is CTO of Thermosome.

  Biopharma is an innovative field with products often developed for a global market. The last years brought several innovative concepts to improve efficiency in the global technical and regulatory environment that we will present and discuss. Regarding manufacturing effectiveness, you will get information on upcoming guidances in the US related to Advanced Manufacturing and Continuous Manufacturing. Regarding regulatory effectiveness, ICH Q12 on post-approval changes is now in its fifth year, so we will reflect on its potential to improve lifecycle management efficiency and improve harmonization across Regulatory Agencies. Another opportunity to support harmonization and smoothen the submission pathway is Accumulus Synergy. This non-profit corporation intends to support interactions between industry and health authorities worldwide to enable real-time collaboration and data exchange, as well as data submission. A pilot study will be presented that shares experience from using this platform in simultaneous submission to multiple Health Authorities. After the talks, the speakers, coming from industry, research organizations, and regulatory agencies, will be available for your questions in a final panel discussion, which will also cover any final questions and reflection on the whole Conference.

  • 15:20 – 15:45

    Simultaneous Submission to Multiple Health Authorities Using Accumulus Synergy Platform - Using CMC Platform Best Practices for Comparability Assessments and Manufacturing Process Validation as Pilot

    • Presenter: Olga Rovira, Regulatory Affairs Senior Consultant, CEPI

      

      Olga Rovira, Regulatory Affairs Senior Consultant, CEPI
      

      Olga Rovira has an academic background in Industrial Chemistry Engineering from the University of Zaragoza (Spain) and in Structural Molecular Biology from the University of London (UK). Olga is currently working at KONTIVAX, her own Regulatory Affairs (RA) consultancy company, which serves small biotech companies, large multinational corporations as well as partnerships such as CEPI (Coalition for Epidemic Preparedness Innovations) or TBVI (TuBerculosis Vaccine Initiative). Her expertise focuses on RA Chemistry, Manufacturing and Controls (CMC) for vaccines. She has a solid knowledge and understanding of technical development of vaccines throughout the whole development path up to registration and subsequent life-cycle stage and how this relates to worldwide regulatory requirements and expectations. Her experience covers multiple vaccine platform technologies as well as adjuvants (novel and well-established). Olga is member of TOPRA (The Organisation for Professionals in Regulatory Affairs).

  • 15:45 – 16:30

    Plenary Discussion

    • Moderator: Sabine Hauck, Dr, Consultant, _

      

      Sabine Hauck, Dr, Consultant, _
      

      Sabine Hauck has 20+ years of experience in the biotech industry, in which she held various positions in pharmaceutical development, quality assurance and regulatory affairs. Her experience spans from small molecules to cell therapies and includes a variety of dosage forms.Currently, Sabine is a freelance consultant for biopharma product development and is CTO of Thermosome.

    • Panelist: Thomas Stangler, PhD, Regulatory CMC Director, Sandoz

      

      Thomas Stangler, PhD, Regulatory CMC Director, Sandoz
      

      Thomas is a Regulatory CMC Director at Sandoz with 15 years of experience in developing Biosimilars for Sandoz and innovative medicines for Novartis. He holds an M.Sc. in physics and a PhD in biochemistry. He is interested in enhanced/QbD approaches to the development of Biologics and the implementation of the corresponding ICH guidances. After ICH Q8, Q9, and Q11, ICH Q12 is for him the next logical step in ensuring product quality throughout the pharmaceutical lifecycle.

    • Panelist: Olga Rovira, Regulatory Affairs Senior Consultant, CEPI

      

      Olga Rovira, Regulatory Affairs Senior Consultant, CEPI
      

      Olga Rovira has an academic background in Industrial Chemistry Engineering from the University of Zaragoza (Spain) and in Structural Molecular Biology from the University of London (UK). Olga is currently working at KONTIVAX, her own Regulatory Affairs (RA) consultancy company, which serves small biotech companies, large multinational corporations as well as partnerships such as CEPI (Coalition for Epidemic Preparedness Innovations) or TBVI (TuBerculosis Vaccine Initiative). Her expertise focuses on RA Chemistry, Manufacturing and Controls (CMC) for vaccines. She has a solid knowledge and understanding of technical development of vaccines throughout the whole development path up to registration and subsequent life-cycle stage and how this relates to worldwide regulatory requirements and expectations. Her experience covers multiple vaccine platform technologies as well as adjuvants (novel and well-established). Olga is member of TOPRA (The Organisation for Professionals in Regulatory Affairs).

    • Panelist: Anna Czwarno, Ms.Eng., Regulatory, Manufacturing & Supply Director, Vaccines Europe, Vaccines Europe

      

      Anna Czwarno, Ms.Eng., Regulatory, Manufacturing & Supply Director, Vaccines Europe, Vaccines Europe
      

      Anna Czwarno, M. S.C. Eng. Anna Czwarno is a Regulatory, Manufacturing & Supply Director at Vaccines Europe, a specialised group within the European Federation of Pharmaceutical Industries and Associations (EFPIA), representing the R&D - based pharmaceutical industry in Europe. She oversees the regulatory, manufacturing and supply topics for vaccines. She joined Vaccines Europe/EFPIA in April 2016. Anna brings more than 20 years of experiences working in the pharmaceutical industry sectors (Lilly, Bayer, Novartis pharma and Novartis vaccines) as well educational. Anna, a Polish national, holds a Master’s degree from the Warsaw University of Technology, Faculty of Chemical and Process Engineering (1993) and postgraduate studies at the Warsaw University Faculty of Pedagogy.

    • Regulatory Panelist: Mats Welin, MScPharm, Scientific director, Biotechnology, Medical Products Agency, Sweden

      

      Mats Welin, MScPharm, Scientific director, Biotechnology, Medical Products Agency, Sweden
      

      Mats Welin holds a position as a Senior expert at the Medical Products Agency in Sweden, working with quality assessment of human and veterinary biologics and normative work within this field. He is a pharmacist by training and has been employed at the agency since 1988. Since 1996 he is the Swedish delegate of CHMPs sub group on biologics, the Biologics working party (BWP) and has in addition to assessments of MAAs and scientific advices also been involved in writing of many guidelines and other normative work in the field as well as been involved in EMA-Industry workshops on setting of specifications, QbD, prior knowledge and accelerated procedures. He is an alternate Swedish delegate to the European Pharmacopoeial Commission and have been involved in WHO work, in particular on requirements to post approval changes to human vaccines. He is the EU regulator topic lead in the revision of ICH Q6 on specifications and was also a delegate of the Quality implementation working group (Q-IWG) of the ICH to work with introduction of the Q8-Q10 concepts. He is frequent speaker at conferences on Quality by Design, process validation, setting of specifications and on general aspects in relation to biological medicinal products.

    • Regulatory Panelist: Steffen Gross, Head Section Qualtiy and Non-clinical Evaluation of Antibody Therapeutics, Paul-Ehrlich-Institute

      

      Steffen Gross, Head Section Qualtiy and Non-clinical Evaluation of Antibody Therapeutics, Paul-Ehrlich-Institute
      

      Steffen Gross has extensive experience in molecular and cell biology. Mr. Gross joined the Paul-Ehrlich Institute in 2005 and became Head of the Section monoclonal and polyclonal antibodies in 2012. Due to re-structure of the section he became Head of Section Quality and Non-clinical Evaluation of Antibody therapeutics” in 2022. He is involved in the assessment of the quality and preclinical issues for marketing authorization applications, scientific advices and clinical trial applications. Until 2012 Mr. Gross was laboratory head of the section monoclonal and polyclonal antibodies and involved in testing of immunoglobulins, immunosera and monoclonal antibodies. Before joining the Paul-Ehrlich Institute he worked in the Netherland for three years as a postdoc. During this time he had been working several months at the National Institute of Health in Bethesda. After his return to Germany in 2001 he became a research group leader at the University of Frankfurt.

    • Academic Panelist: Maria Papathanasiou, PhD, Associate Professor (UK Senior Lecturer), Department of Chemical Engineering, Imperial College London

      

      Maria Papathanasiou, PhD, Associate Professor (UK Senior Lecturer), Department of Chemical Engineering, Imperial College London
      

      Dr Maria Papathanasiou is a Senior Lecturer (AssociateProfessor) at the Department of Chemical Engineering, Imperial College London. She holds a PhD degree in Process Systems Engineering from the Department of Chemical Engineering at Imperial College London and an MSc from the same department. She completed her undergraduate studies at the School of Chemical Engineering, National Technical University of Athens and she conducted her Diploma Thesis in Food Process Engineering at the Technical University of Berlin. Dr Papathanasiou’s research focuses on the development of Process Systems Engineering tools (modelling, optimisation and control) with application to biopharmaceutical process development, optimisation and control. Her research outputs to date have been acknowledged through over 40 peer reviewed and conference publications, 30 oral presentations at international conferences and 4 international awards, including IChemE’s Junior Sargent Medal (2023).

    • Panelist: Paul Matejtschuk, PhD FRSC CChem, Section Head Formulation Science, MHRA

      

      Paul Matejtschuk, PhD FRSC CChem, Section Head Formulation Science, MHRA
      

      Biography: Paul Matejtschuk PhD, CChem, FRSC leads the Formulation Science Section at the Medicines and Healthcare products Regulatory Agency, at their South Mimms laboratories, in the UK, whose mission is to safeguard the quality of biological medicines. He has over 20 years experience of developing freeze drying and formulation conditions for a wide range of biological materials including those developed on behalf of the WHO as International Reference Standards for Biological Standardization. His team is focused on delivering formulation and lyophilization conditions and his research interests include Process Analytical Technology in freeze drying, the relationship between structure and stability in biologicals, thermal analysis and other methods for the characterization of lyophilized proteins. Paul Matejtschuk (0000-0002-4646-800X) - ORCID Paul has over 35 years postdoctoral experience working in both academic and industrial settings in the areas of biologicals, with broad experience across downstream processing, characterization and analysis. He is a Director of the International Society for Lyophilization/Freeze Drying (www.islyophilization.org) and a committee member of the Thermal Methods Group of the Royal Society of Chemistry (www.thermalmethodsgroup.org.uk). Email: paul.matejtschuk@mhra.gov.uk

    • Moderator: Cristiana Campa, PhD, Technical R&D Advisor, GSK

      

      Cristiana Campa, PhD, Technical R&D Advisor, GSK
      

      Cristiana Campa, PhD, is currently a Technical R&D Advisor at GSK Vaccines, with involvement in CMC development portfolio support and scientific advocacy, focusing on CMC strategies and innovation, with active participation in several cross-company working groups (e.g.,PDA, EFPIA/ Vaccines Europe, IFPMA). She has more than 20 years experience in biologics and related analytical and development approaches, gained in different universities and companies. She joined Novartis Vaccines in 2006, focusing on development, validation and transfer of analytical methods for release and characterization of several vaccine products, first as senior manager and then as Head of Analytical Development, Italy. Since 2012, Cristiana has worked on Quality by Design (QbD) principles implementation for vaccines. After acquisition of Novartis Vaccines by GSK in 2015, she has been the Head of QbD Integration and, until June 2018, the Head of Science and Development Practices in Technical R&D, covering QbD implementation, Knowledge Management and Development roadmaps. Since 2023, Cristiana is an elected member of the PDA Board of Directors. Since 2024, she is the co-chair of the PDA Vaccine Interest Group, and a member of the ICH Expert Working Group dedicated to ICHQ6 Guideline (Specifications) revision (EFPIA lead).

    • Regulatory Panelist: Robin Levis, PhD, Deputy Director, Division of Viral Products, OVRR, CBER, U.S. FDA

      

      Robin Levis, PhD, Deputy Director, Division of Viral Products, OVRR, CBER, U.S. FDA
      

      Dr. Robin Levis has worked at the US Food and Drug Administration since 1995. She is currently the Deputy Director of the Division of Viral Products in the Office of Vaccines Research and Review at CBER/FDA. Prior to this position, she served as the Regulatory Coordinator for the Division of Viral Products and as a Senior Staff Fellow in the Laboratory of Vector Borne Viral Diseases. In addition to her work in the Office of Vaccines at CBER, she has served as the CBER representative to ICCVAM, as an observer to EDQM Group 15 for vaccines, a member of the WHO/NC3Rs working group, and serves on several vaccine working groups for the Coalition for Epidemic Preparedness Innovations. Her role on these International working groups is to encourage global regulatory harmonization and to provide regulatory support related to CMC development and product quality for viral vaccines and to the development of alternative, non-animal-based quality assays.

• 16:30 – 16:40

  Co-Chair Conference Summary

  Banquet Hall 1

  • Co-Chair: Sabine Hauck, Dr, Consultant, _

    

    Sabine Hauck, Dr, Consultant, _
    

    Sabine Hauck has 20+ years of experience in the biotech industry, in which she held various positions in pharmaceutical development, quality assurance and regulatory affairs. Her experience spans from small molecules to cell therapies and includes a variety of dosage forms.Currently, Sabine is a freelance consultant for biopharma product development and is CTO of Thermosome.

  • Co-Chair: Sabine Hauck, Dr, Consultant, _

    

    Sabine Hauck, Dr, Consultant, _
    

    Sabine Hauck has 20+ years of experience in the biotech industry, in which she held various positions in pharmaceutical development, quality assurance and regulatory affairs. Her experience spans from small molecules to cell therapies and includes a variety of dosage forms.Currently, Sabine is a freelance consultant for biopharma product development and is CTO of Thermosome.
• 16:40 – 16:45

  Closing Remarks & Farewell

  Banquet Hall 1

  • Committee Member: Falk Klar, PhD, General Manager, Vice President Europe, Parenteral Drug Association

    

    Falk Klar, PhD, General Manager, Vice President Europe, Parenteral Drug Association
    

    Falk Klar holds a Ph.D. in Applied Physics and has over 19 years of experience in Quality Assurance and Compliance in the life science industry. Falk held positions in pre-clinical research and development in a medical product company and clinical research in a CRO. He has gained experience with biopharmaceutical and pharmaceutical products including monoclonal antibodies, vaccines, parenteral, narcotics, and animal drugs in several positions in quality management. Falk joined PDA Europe in 2015 as Senior Director of Training & Education. Since 2016 he has been appointed General Manager and Vice President of PDA Europe.

Posters

• Andrea Weiss

• Sarah S. Peláez, PhD Student & Senior Scientist Primary Packaging, ten23 health

• Samuel Dorey, PhD, Principal Scientist Materials & Irradiations, Sartorius

• Natalie Hoerberger

• Christof Hasse

• Will Pierce

• Nicole Haerdter

• Cecilia Annerén

• John Betts