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2023 BioLyo-1988x680

2023 PDA BioManufacturing Conference

Sep 12 - Sep 13, 2023
Seville, Spain

Agility and Biomanufacturing Excellence to Meet Patient’s Needs

  • Conference
  • Europe

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Program Highlights

AGENDA is out NOW!


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 Patient’s 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 like an extensive forum for sharing knowledge, 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.


The Chairs

Cristiana Campa, GSK
Elisabeth Vachette, Sartorius 


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


  • Day 1
  • Day 2
  • Tuesday, 12 September 2023


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

    Opening Session: Agility and Biomanufacturing Excellence to Meet Patient's Needs
    Moderator: Cristiana Campa, GSK & Elisabeth Vachette, Sartorius

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

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

    Title to be Announced
    Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)

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

    Title to be Announced
    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

    Session 1 Track A: Application of AI and ML for Biopharmaceutical Development and Manufacturing
    Moderator: Michael De Felippis, Eli Lilly

    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

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

    Q&A, Discussion

    Session 1 Track B: The Power of Modelling and Microwaves in Lyophilization
    Moderator: Julian Lenger, Bayer

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

    Effect of the Freezing Step on Primary Drying Experiments and Simulation of Lyophilization Process
    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

    Session 2 Track A: Advanced Modeling Strategies for Product and Process Understanding
    Moderator: Sabine Hauck, Leukocare

    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

    Session 2 Track B: Formulation / Fill and Finish
    Moderator: Yves Mayeresse, GSK

    Environmental and Process Monitoring (Viable and Total Particle) According to the 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, MSD

    Q&A, Discussion

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

  • Wednesday, 13 September 2023

    Concurrent Sessions

    Session 3 Track A: Sustainability
    Moderator: Susanne Joerg, ten23 health

    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

    Session 3 Track B: Enhancements in Supply Capacity
    Moderator: Elisabeth Vachette, Sartorius

    MIntensification 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

    Session 4 Track A: Vaccines
    Moderator: Florence Wauters, Merck

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

    Specifications for Vaccines
    Julia O'Neill, Moderna

    Q&A, Discussion

    Session 4 Track B: Advances in Biotherapeutics Developments and Life Cycle
    Moderator: Sabine Hauck, Leukocare

    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, DPS Group

    Q&A, Discussion

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

    Closing Session: Health Emergencies Preparedness for the Future
    Moderator: Cristiana Campa, GSK & Elisabeth Vachette, Sartorius

    Interactive Questionnaire

    Accelerating Access to Vaccines – Next Steps Beyond the Pandemic
    Mic McGoldrick, MSD

    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

    Learning on Future Pandemics for Use of Prior Knowledge
    Regulatory Speaker Invited

    Quality Innovation Group and Other EMA Activities in the Biotech Area  
    Elisa Pedone, EMA

    Closing Panel Discussion

    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

Additional Information

  • Who Should Attend
    Pharma Companies
    • Biopharmaceutical Companies
    • Start-ups/Emerging Companies
    • Raw Materials
    • Consumables
    • Equipment
    Governmental Health Authorities
    • National/Local Authorities
    • European Authorities
    • International Authorities
    Service Providers
    • CDMOs
    • Contract Test Laboratories
    • Logistic Companies
    • Freelancer
    • Consulting Firms
    • Universities
    • Academic Research Institutes

Got a Question? We have answers

Contact Us


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
Phone: +34 954 57 94 00

Make a Reservation
  • Accommodations

    PDA recommends the reservation at the following hotel

    Melia Lebreros
    C. Luis de Morales, 2
    41018 Seville

    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.

  • Amenities

    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.

Other Options

Only 30 minutes by train from the airport to the hotel.


Registration Fees

Early Registration
Registration Type Price by 16 July
Member €1.845
Non-member €2.145
Govern./Health Authority/Academic €870
Early Career Professional (Member) €870

Regular Registration
Registration Type Price after 16 July
Member €2.045
Non-member €2.345
Govern./Health Authority/Academic €970
Early Career Professional (Member) €970

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].


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