2023 PDA BioManufacturing Conference

12 Sep - 13 Sep 2023
Seville, Spain

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Program Highlights

See you in Seville / Spain!

Dear Colleagues,

We are looking forward to welcoming you to the 5th anniversary edition of 2023 PDA BioManufacturing Conference, taking place on 12 – 13 September 2023 in Seville, Spain.

The 2023 theme, Agility and Biomanufacturing Excellence to Meet Patients' Needs, will link our final goal of “Improving Patient’s Health” to our industry, targeting sustained improvement and flexibility in biomanufacturing processes.

This conference will be built as an extensive forum for sharing knowledge and experiences on the way to develop new modalities and on the most innovative solutions for agile biomanufacturing as well as on the latest advancements for regulatory aspects. This conference covers many modalities like vaccines, monoclonal antibodies, and new drug modalities from early development until commercial cGMP manufacturing, with focus on product, process and analytical advances.

By joining this conference, you will be able to dive into latest regulatory up-dates, adaptive manufacturing solutions presented by regulatory agencies’ representatives, industry experts, as well as early career professionals, not forgetting the wonderful opportunity to network.

Sincerely,

The Co-Chairs

Cristiana Campa, GSK
Elisabeth Vachette, Sartorius 

SCIENTIFIC PROGRAM PLANNING COMMITTEE

  • Cristiana Campa, GSK 
  • Elisabeth Vachette, Sartorius 
  • Thomas Beutler, GEA Lyophil
  • Michael De Felippis, Eli Lilly
  • Sabine Hauck, Leukocare
  • Julian Lenger, Bayer
  • Susanne Joerg, ten23 health 
  • Yves Mayeresse, GSK
  • Florence Wauters, Merck Sharp & Dohme
  • Josh Eaton, PDA
  • Falk Klar, PDA Europe
  • Sabine Hartmann, Manager Programs & Events, PDA Europe

Agenda

Discover What's Happening Each Day
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Day 1 12 Sep Day 2 13 Sep
Tuesday, 12 September

Tuesday, 12 September 2023

09:00

Welcome and Introduction
Falk Klar, PDA
Cristiana Campa, GSK
Elisabeth Vachette, Sartorius

09:15 - 13:00 I Opening Session: Agility and Biomanufacturing Excellence to Meet Patients' Needs
Moderators: Cristiana Campa, GSK & Elisabeth Vachette, Sartorius
With the theme of this year: Agility and Biomanufacturing Excellence to meet Patients’ Needs the 5th PDA Biomanufacturing Conference provides key trends and latest development in Bioindustry. The first plenary session will provide extensive reflection on regulatory framework for innovations in Chemistry, Manufacturing and Controls (CMC) for biotherapeutics and vaccines, showcasing opportunities and examples of collaboration between Industry and Regulatory Agencies to drive implementation of new technologies and digital strategies in the biopharmaceutical area. Furthermore, perspectives on accelerated CMC development roadmaps will be provided by CEPI, also reflecting on the interdependency between innovation and rapid access to patients.

Regulatory Framework for Biomanufacturing Innovations
Mats Welin, Medical Products Agency Sweden

Artificial Intelligence and Digital Twins in Biopharma Manufacturing
Toni Manzano, Aizon

Quality Innovation Group: Regulatory Support for Innovative Manufacturing and Quality Control Approaches
Marcos Timón, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)

10:45 - 11:15 | Coffee Break, Poster Session & Exhibition

The IMI Inno4Vac Project: A Public-Private Partnership Focussing on Innovations to Accelerate Vaccine Development and Manufacture
Wim Van Molle, Sciensano Belgium

Phase Appropriate CMC Deliverables for Vaccine Development
Anna Särnefält, CEPI

Q&A, Panel Discussion

13:00 - 14:15 | Lunch Break, Poster Session & Exhibition

13:45 - 14:15 | Guided Poster Walk - Engage with our Poster Presenters in our Exhibition Hall
Moderator: Thomas Beutler, GEA Lyophil

Concurrent Sessions

14:15 - 16:00 I Session 1 Track A: Application of AI and ML for Biopharmaceutical Development and Manufacturing
Moderator: Michael De Felippis, Eli Lilly
Artificial Intelligence (AI) and Machine Learning (ML) tools are increasingly being deployed across multiple industries to unlock new value and gain efficiency.  The biopharmaceutical industry is recognizing the important role AI/ML can play in improving processes for development and commercialization and accelerating innovative medicines to patients.  This session includes three applications of AI/ML including repurposing AI technology implemented at an unrelated industry for a biopharmaceutical manufacturing process, using ML modeling to increase efficiency and probability of technical success for drug candidates in early-phase development, and creating an ML algorithm to optimize excipient selection for biopharmaceutical formulations.

Model-Driven AI in Operations Management: From Space Exploration to Real World Bio-Manufacturing
Jonas Gibaszek, Rombio

Predicting Holistic Developability Scores for Protein Scaffolds Using Machine Learning  
Daniel Pais, Valgenesis & Karin Felderer, Pieris Pharmaceuticals

Machine-Learning Acceleration of Biopharmaceutical Formulation Development Using Excipient Prediction Software (ExPreSo)  
Estefania Vidal-Henriquez, Leukocare

Q&A, Discussion

14:15 - 16:00 I Session 1 Track B: The Power of Modelling and Microwaves in Lyophilization
Moderator: Julian Lenger, Bayer
Explore the scientific advancements in lyophilization through the application of modeling techniques and the utilization of microwaves. Gain insights into how modeling enhances the optimization of lyophilization cycles by guiding the selection of process parameters for desired product attributes. Discover the impact of the freezing step on drying efficiency and product quality and learn about the influence of controlled nucleation on primary drying simulation accuracy. Dive into the scientific principles of microwave-assisted freeze-drying (MFD), uncovering its potential to significantly reduce drying times while maintaining product integrity. Join us to delve into the scientific aspects of lyophilization optimization and the utilization of innovative technologies.

Modelling the Lyophilization Process: A Quality by Design Approach to Optimize Cycle Performance and Product Quality
Andrea Arsiccio, Coriolis Pharma Research 

Effect of the Freezing Step on Primary Drying Experiments and Simulation of Lyophilization Processes
Alex Juckers, Martin Christ

A Novel Way of Freeze-Drying: Drastic Drying Time Reduction Using Microwave Radiation
Benjamin Ledermann, GEA Lyophil

Q&A, Discussion

16:00 - 16:30 | Coffee Break, Poster Session & Exhibition

16:30 - 17:50 I Session 2 Track A: Advanced Modeling Strategies for Product and Process Understanding
Moderator: Sabine Hauck, Leukocare
Modelling of processes bears the two-fold advantage of deeper process understanding and gaining speed. Kinetic modelling is a powerful tool to predict process outcome based on real data and process understanding. The speakers in this session will present the success stories of kinetic modelling for manufacturing process on one side, and stability prediction on the other side.

Quantifying the Catabolism of CHO Cells to Build Industrially Relevant Kinetic Models
Sergio Rossell, GSK

A Universal Tool for Stability Predictions of Biotherapeutics, Vaccines and In Vitro Diagnostic Products 
Didier Clénet & Warren Roche, Sanofi

Q&A, Discussion

16:30 - 17:50 I Session 2 Track B: Formulation / Fill and Finish
Moderator: Yves Mayeresse, GSK
The requirements for drug products evolved over the years to obtain a better quality. This evolution can come from new rules or from innovation. The first presentation will discuss how important requirements of the European GMP Annex 1:2022 have changed the qualification of cleanrooms. Continuous environmental monitoring represents one of the most relevant and effective tools to assess in real time the potential risk of contamination in critical environments. With a second presentation we will learn how to design a more resilient vial to physical insults thus minimizing breakage and having better machining capability when compared to existing borosilicate vial. The challenge of implementing these vials and the need to revise USP/EP to broaden the definition of Type I pharmaceutical glass and gaining the approval by US FDA will be explained.

Environmental and Process Monitoring (Viable and Total Particle) According to the EU GMP Annex 1:2022 - New Requirements and Next Challenges
Diego Bompadre, Rigel Life Sciences

Regulatory Journey to Approval of a Novel Final Product Container
Navdip Ghai, Merck Sharp & Dohme

Q&A, Discussion

17:50 | End of Conference Day 1 and Networking Event

Wednesday, 13 September

Wednesday, 13 September 2023

Concurrent Sessions

09:00 - 10:20 I Session 3 Track A: Sustainability
Moderator: Michael De Felippis, Eli Lilly
While the pharmaceutical industry is recognized for its unique position on creating value to patients and society based on innovations, expectations have raised in recent years to put focus on sustainability. To achieve the goal of climate neutral operations and supply chain within pharmaceutical industry, it is of crucial importance to implement sustainability targets already from the beginning into the design of pharmaceutical products. In the first presentation industrial case studies are presented on how to meet sustainability targets in context of the existing regulatory frameworks, following the second presentation on how strategies can support sustainability, considering both process design and optimization (mAb example) and techno-economic assessment and modeling (viral vector example) by showing us on how to build these targets from the beginning into the product and process design.

Building a Regulatory Framework to Support Innovation to Medicines Supply to Meet, Patient Access, Environmental and Climate Targets
Mónica Perea-Vélez, GSK

Embedding Sustainability in Process Design and Product Distribution
Maria Papathanasiou, Imperial College London

Q&A, Discussion

09:00 - 10:20 I Session 3 Track B: Enhancements in Supply Capacity
Moderator: Elisabeth Vachette, Sartorius
Drug availability is one of the key drivers of our industry and serving patients means that drug manufacturing processes must be flexible and resilient enough to cope with numerous constraints including current demand variability. This session will focus on 2 aspects having demonstrated their ability to better serve patients, namely by developing novel processes and increasing flexibility and speed to market via process intensification implementation and via rapid process and regulatory scalability for biologics enabling mass production.

Intensification of mAbs by Connected Processing: Development to Scale Up to Ensure Robust, Cost Effective, and Fast Manufacturing
Sanket H. Jadhav, Sartorius

Biopharma 4.0 for Biologics Under Pandemic Constraints - Scalable mRNA Machine for Regulatory Approval of 1,000 Clinical to 10 Million Manufacturing Scale Doses
Alina Hengelbrock & Axel Schmidt, TU Clausthal

Q&A, Discussion

10:20 - 10:50 | Coffee Break, Poster Session & Exhibition

10:50 - 12:10 I Session 4 Track A: Vaccines
Moderator: Yves Mayeresse, GSK
The first presentation will provide general principles on specification setting for different vaccine types, as well as some illustrative examples, showing how to overcome some challenges and providing reflections on future directions as there is no predefined and single set of specifications’ quality attributes for vaccines against a given pathogen, since multiple vaccine platforms can be used for the same target. The next presentation will focus on the PDA technical report 89: Strategies for vaccine development and life cycle management. 

PDA Technical Report n 89 (Strategies for Vaccine Development and Lifecycle Management
Sabrina Restrepo, Merck Sharp & Dohme

Specifications for Vaccines
Julia O'Neill, Direxa Consulting

Q&A, Discussion

10:50 - 12:10 I Session 4 Track B: Advances in Biotherapeutics Developments and Life Cycle
Moderator: Sabine Hauck, Leukocare
Developments in biotherapeutic manufacturing will be illustrated for antibodies and cell -based therapies. A case study of a commercial platform mAb process and its global post-approval changes will provide lessons learned with respect to ensuring streamlined lifecycle management. The second talk will discuss allogeneic cell therapies and their potential as “off-the-shelf” products.

Lifecycle Management of a Commercial Platform Monoclonal Antibody Process: The Promise of ICH Q12
Cillian McCabe, Eli Lilly

What the cell? Next Generation Allogeneic Cell Therapies and Impact on Facility Design
Emily Heffernan, Arcadis DPS Group

Q&A, Discussion

12:10 - 13:10 | Lunch Break, Poster Session & Exhibition

13:10 - 16:50 I Closing Session: Health Emergencies Preparedness for the Future
Moderators: Cristiana Campa, GSK & Elisabeth Vachette, Sartorius
The closing plenary session will explore progress of implementation of pandemic- related learnings from Industry and Regulators, including concrete initiatives from vaccines developers and new guidance tools from Health Authorities, especially in case of epidemic or pandemic scenarios. We will benefit from key experts and take the opportunity to network and exchange with EMA and U.S. FDA, as well as from Global Health- driven organizations like CEPI to accelerate development and supply of biopharmaceuticals and provide innovative tools for comparability assessment and process validation. Our common goal is to meet patient’s needs through agility and biomanufacturing excellence.

Interactive Questionnaire

Accelerating Access to Vaccines – Next Steps Beyond the Pandemic
Mic McGoldrick, Merck Sharp & Dohme

Platform Protocol Templates: An Innovative Upcoming Tool for Comparability Assessment and Process Validation
Antonio Guzzi, CEPI

14:15 - 14:45 | Coffee Break, Poster Session & Exhibition

14:45 - 14:50 | Passport Raffle

Expedited Product Development – Learning from Pandemics
Anissa Cheung, US FDA

EMA CMC Toolbox: Facilitating Early Access of Biopharmaceuticals in the EU  
Elisa Pedone, EMA

Closing Panel Discussion 
Join our Discussion with Experts from Industry and Regulatory 

- Anissa Cheung, US FDA
- Antonio Guzzi, CEPI 
- Mic McGoldrick, Merck Sharp & Dohme
- Maria Papathanasiou, Imperial College London
- Elisa Pedone, EMA
- Mats Welin, Medical Products Agency Sweden
- Wim Van Molle, Sciensano Belgium

Co - Chairs Conference Summary
Cristiana Campa, GSK
Elisabeth Vachette, Sartorius

Closing Remarks & Farewell
Falk Klar, PDA Europe

16:50 | End of Conference

The agenda is subject to change without notice, speakers are invited, pending confirmation

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Location and Travel

Venue Details and Accommodations

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Melia Lebreros

C. Luis de Morales, 2
Seville, Spain

+34 954 57 94 00

Make a Reservation Online

PDA recommends the reservation at the following hotel

Melia Lebreros
C. Luis de Morales, 2
41018 Seville
Spain

Tel: +34 954 57 94 00

PDA Europe has reserved a limited number of rooms by 01 August 2023.

Book your room at the PDA Group Rate via the above-mentioned reservation button.


The hotel is located in the heart of Seville, next to the Royal Alcazar and the Plaza de Espana including a 270 qm swimming pool and a fully equipped fitness area.

How to Get Here
By Air The hotel is only 8 kilometers away from Seville International Airport.
By Car On site parking is available. Please contact the hotel for more information.

Registration

Pricing Options

Standard Registration

Member Price

€2.045

GovernmentMember Only

€970

Health AuthorityMember Only

€970

Early Career ProfessionalMember Only

€970

AcademicMember Only

€970

Non-Member

€2.345

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

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