PDA Europe Virtual Conference - BioManufacturing
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Manufacturing science and technology continues to play an essential role in enabling biopharmaceutical innovation. While biopharmaceuticals comprise multiple molecular formats, there are important similarities connecting the different production platforms used for manufacturing. This connectivity provides ample opportunities to share key knowledge and learning across various product types and associated scientific disciplines. In line with its mission of connecting people, science and regulation, PDA Europe has recognized the need for a forum to communicate information and facilitate interaction in the field of biopharmaceutical manufacturing. Following a successful inaugural event in 2019, PDA Europe is proud to announce the second edition of BioManufacturing, this year presented as a Virtual Conference on 22-23 September 2020.
The 2020 conference will provide an exceptional opportunity to present the latest innovative approaches for biopharmaceutical manufacturing and discuss hot topics related to process, product, analytics and regulatory strategies with a broad audience, including representatives from companies, academic research institutions, regulatory agencies and Official Medicines Control Laboratories. A variety of biopharmaceutical product classes will be considered, including Therapeutic Proteins and Vaccines..
The program will be accompanied by interactive activities and virtual networking opportunites! A vendor exhibition featuring the latest manufacturing technologies and materials will also complement a strong agenda of knowlegdable experts on the online platform!
Sincerely,
The Chairs
Michael De Felippis, PhD
Eli Lilly and Company
Cristiana Campa, PhD
GSK Vaccines
Program Highlights
The 2020 PDA Europe Virtual BioManufacturing Conference will focus on Driving Biopharmaceutical Innovation and Sustainability!
Don't miss the LIVE Q&As and Panel Discussions with distiguished experts from the industry and regulatory representatives from the Paul-Ehrlich-Institut, EMA, as well as the Swedish and Belgian Agencies!
Sign up today!
Agenda
Discover What's Happening Each Day
Tuesday, 22 September 2020
Module I: Welcome & Opening
12:00 - 12:30 CEST
| Welcome & Introductions | Falk Klar, PDA Europe |
| Welcome from the Chairs | Cristiana Campa, GSK Vaccines, Chair Michael De Felippis, Eli Lilly & Company, Chair |
|
Keynote: Industry 4.0 and Regulatory Advances to New Technologies |
Maeve Lally, HPRA |
Transition Break
12:30 - 12:35 CEST
Module II: Accelerating Biopharmaceutical Innovation
12:35 - 14:05 CEST
| Accelerating Biopharmaceutical Innovation |
Moderators: |
| COVID-19 Biologics- Procedural Aspects and Quality Scientific Considerations in the Context of The Crisis – an EMA Perspective | Ragini Shivji, European Medicines Agency |
| How to Facilitate CMC Development in Pandemic Situations | Steffen Gross, Paul-Ehrlich-Institut |
| Specifications for Biologics and the Use of Prior Knowledge for Biotherapeutics and Vaccines – Manufacturing | Mats Welin, Medical Products Agency Sweden |
|
Live Q & A, Discussion |
Virtual Networking & Exhibition
14:20 - 15:15 CEST
Module III: Accelerating & Sustaining Access to Innovative Biologics & Vaccines
14:20 - 15:15 CEST
| Accelerating & Sustaining Access to Innovative Biologics & Vaccines |
Moderators: |
| The EMA PRIME Procedure in an Accelerated Assessment Environment for Vaccine Licensure: Experiences from Quality (CMC) Assessors – a Case Study for an Ebola Vaccine | Wim Van Molle, Sciensano |
| Developing ERVEBO® to Address a Worldwide Health Concern | Kay Hunsberger, MSD |
|
Live Q & A, Discussion |
Virtual Networking & Exhibition
15:15 - 16:15 CEST
Module IV: Robotics & Lifecycle Management
16:15 - 17:45 CEST
| TRACK A – ROBOTICS | TRACK B – LIFECYCLE MANAGEMENT | ||
| Moderators: Richard Denk, SKAN Lucia Ceresa, Charles River |
Moderators: Jonny Parsons, Amgen Cristiana Campa, GSK Vaccines |
||
| In biomanufacturing robotics take over complex or monotone working procedures in some areas. Gloveless isolators with integrated robotic solutions are an additional trend in aseptic processing. During aseptic Fill & Finish robotics perform almost all activities without human intervention to improve product safety. Robotics are modern novel technologies to improve the product quality with validated and reproductible operation. | This session provides an overview on recent considerations for lifecycle management. What can we expect in the future from analytical methods and validation concepts? How can principles of quality risk management be applied to vaccine development and lifecycle? The pragmatic constraints and practical risk mitigation measures with consideration for current regulatory expectations and commercial manufacturing process robustness will be discussed. | ||
| Possibilities for Modern Robotics in Biopharma | Christine Eckardt, PM Group | Managing Charge Heterogeneity Through a Product's Lifecycle | Cillian McCabe, Eli Lilly & Company |
| Facility of the Future: an Aseptic Smart, Modular, Gloveless Robotic Filling Isolator Technology | Thomas Thurn & Dieter Bachmann, Janssen Pharmaceuticals - a J&J company | Comparability in Development and Lifecycle of Biological Products | Simona Cianetti, GSK |
| Robotics, Inspection and Automation Ensuring Quality & Compliance | John Walshe, Ward Automation | A Vision of The Future of Analytical Method Life Cycle Management: Towards Flexible Business Operations Allowed by Data-Driven Continuous Control | Jean-Francois Dierick, GSK Vaccines |
| Live Q & A, Discussion | Live Q & A, Discussion | ||
Virtual Networking Event
17:45 - 18:45 CEST
| Meet Your Peers in Our Networking Lounges | |
| Lounge I | Meet the Regulators |
| Lounge II | Control Strategies to Respond to Pandemic Threats: Interest Group Vaccines |
| Lounge III | Technology and Knowledge Transfer: Status of the Technical Report 65 |
| Lounge IV | Meet the Interest Groups BioManufacturing & Process Validation |
Wednesday, 23 September 2020
Module V: Platform Technologies & Environmental Monitoring & Decontamination Strategies
10:00 - 11:00 CEST
| TRACK A – PLATFORM TECHNOLOGIES | TRACK B – ENVIRONMENTAL MONITORING AND DECONTAMINATION STRATEGIES | ||
| Moderators: Sebastian Teitz, Asahi Kasei Mark van Ooij, Janssen Vaccines |
Moderators: Lucia Ceresa, Charles River Walid El Azab, STERIS |
||
| Platform technologies are becoming a popular industry approach for bioprocessing and the approach potentially simplifies transactions & interactions between the stakeholders of biopharmaceuticals product development and manufacturing. This session explores the implications of Quality by Design (QbD) considerations as well as the utilization of new technologies and approaches towards vaccine manufacturing and development. | How to put into practice the Quality Risk Management Principles (QRM) in establishing a robust Environmental Monitoring program is always a timely, relevant and hot topic. The learning objective of this section is to review and address the last updated version 2020 of the PDA Technical Report 13 guidance on Environmental Monitoring. In addition to QRM, the TR will also include practical guidance on Rapid Microbiological Methods (RMM) and automated monitoring systems and more. Moreover, you will learn about the exciting and anticipated proposal for Surface Decontamination Transfer from Grade C or D to a Grade A based on e-beam decontamination and about the upcoming new Technical Paper by PDA on Isolator use. | ||
| Vaccine Platforms: the GMMA Case Study | Francesca Micoli, GSK | Update of the Technical Report TR13 on the Fundamentals of an Environmental Monitoring Program: What’s New? | Kurt Jaecques, GSK Vaccines Marc Glogovsky, Valsource |
| Quality by Design and Techno-Economic Modelling of RNA Vaccine Production | Zoltán Kis, Imperial College London | How to Decontaminate Ready to Use RTU "Nested Vials or Syringes” for the Use in Isolators | Manfred Holzer, SKAN Andreas Kerschbaumer, Novartis |
| Live Q & A, Discussion | Live Q & A, Discussion | ||
Virtual Networking & Exhibition
11:30 - 11:50 CEST
Meet the Poster Presenter:
Moderator: Cristiana Campa, GSK Vaccines
Poster Presenters are invited to present their content in a brief Elevator Pitch in a separate Live Room
Module VI: Process Development & Modelling & Cross-Contamination Control for Highly Potent APIs
11:50 -13:00 CEST
| TRACK A – PROCESS DEVELOPMENT AND MODELLING | TRACK B – CROSS-CONTAMINATION CONTROL FOR HIGHLY POTENT APIS | ||
| Moderators: Mark van Ooij, Janssen Vaccines Jonny Parsons, Amgen |
Moderators: Walid El-Azab, STERIS Susanne Jörg, LONZA |
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| Companies are looking into more and more to compress product development timelines amongst other due to cost involved and competitive landscape. One of the ways to potentially expedite product development is by using modelling approaches. A plethora of modelling approaches are currently available which are used at various stage and to address different aspects in product development. | Cross-contamination control is an essential element of the Contamination Control Strategy (CCS). The CCS is a culmination of an exercise to identify activities designed to prevent microorganisms, pyrogens, and particulates contamination in the product and supporting process used to manufacture the product. During this session, two presentations share their perspective on how to prevent cross-contamination by exploring the modern concept of the cleaning and occupational limit while mixing engineering best design practices and increase regulatory expectations for aseptic processing. | ||
| Model-guided Drug Substance Process Development | Rui Portela, GSK Vaccines | Aseptic Processing: GMP and Occupational Safety Requirements for Highly Potent Substances | Richard Denk, SKAN Reinhold Maeck, Boehringer Ingelheim |
| Impact Quantification of Upstream Process Conditions on End-to-End Bioprocess Performance: A Case Study on Monoclonal Antibodies | Maria Papathanasiou, Imperial College London | Aseptic Meets High-Potent: Setting the Stage for Next Level ADC Processing | Matthias Angelmeier, Syntegon Technologies |
| Live Q & A, Discussion | Live Q & A, Discussion | ||
Break & Virtual Exhibition
13:00 - 13:30 CEST
Module VII: Drug Product Development & Formulation & Container Closure Integrity
13:30 - 14:45 CEST
| TRACK A – DRUG PRODUCT DEVELOPMENT AND FORMULATION | TRACK B – CONTAINER CLOSURE INTEGRITY | ||
| Moderators: Susanne Jörg, LONZA Florence Wauters, MSD |
Moderators: Elisabeth Vachette, Sartorius Stedim Sebastian Teitz, Asahi Kasei |
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| This session focuses on the integrated development and manufacturing approach of Biologics Drug Products, typical challenges and case studies how to rationally approach these. One presentation will cover innovation strategies for continuous improvement utilizing tools such as data analysis and machine learning. Biologics molecules can be quite sensitive with regard to various potential stresses, including temperature, light, mechanical stresses due to shaking or shear, stresses during freezing and thawing but also with regard to potential sensitivity to process residuals, such as extractables and leachables. Another presentation will focus on the potential interaction of excipients like surfactants with the manufacturing process should be watched-out and investigated. | Container closure integrity requirements are in constant evolution. This session will focus on latest scientific and regulatory advancements for Single-Use Systems Integrity (SUSI) and how Container closure integrity is ensured for novel & advanced therapies | ||
| Modernizing Drug Product Development and Manufacturing through Innovation and Application of Data Science and Machine Learning | Nitin Rathore, Amgen | Consistent Robustness and Integrity Testing Lead to Enhanced Process Integrity and Patient Safety | Marc Hogreve, Sartorius Stedim |
| Polysorbate in Biologics – Understanding Degradation by Application of Proper Analytics | Michael Jahn, Lonza Drug Product Services | Dynamic Challenge of Container Sealing Performance for Biologics and Cell & Gene Therapy at Cold Temperature | Qingyu Zeng, WEST |
| Live Q & A, Discussion | Live Q & A, Discussion | ||
Virtual Networking & Exhibition
14:45 - 16:00 CEST
Module VIII: Closing Plenary: Sustainability and Future Directions in Biopharmaceutical Manufacturing
16:00 - 18:15 CEST
| Closing Plenary: Sustainability and Future Directions in Biopharmaceutical Manufacturing | Moderators: Cristiana Campa, GSK Vaccines Michael De Felippis, Eli Lilly |
| How can the New Plastic Economy Influence Pharma and Bioprocesses? | Magali Barbaroux, Sartorius Stedim |
| Single-use Biomanufacturing Waste Management & Recycling | Chor Sing Tan, Cytiva |
Virtual Networking & Exhibition
| A Paradigm Shift in Process Monitoring within a Digital Transformation Program | Anthony Maguire, Eli Lilly & Company |
| Lessons Learned from Implementation of a Data Analytics Solution to Support Biomanufacturing Operations | Gerald Kierans, Pfizer |
LIVE Session: Panel Discussion on Innovations & Sustainability in Pharma with Regulatory and Industry Representatives
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| Conference Summaries by the Chairs | Cristiana Campa, GSK Vaccines, Chair Michael De Felippis, Eli Lilly & Company, Chair |
| Closing Remarks & Farewell | Falk Klar, PDA Europe |
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Crowne Plaza Dublin Airport
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€ 645
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€ 645
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€ 645
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
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