PDA BioManufacturing Conference 2024

Shaping the Future of Biomanufacturing

Gothenburg, Sweden
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Deadline: 09 August 2024

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Dear Colleagues,

We are looking forward to welcoming you to the PDA BioManufacturing Conference 2024 taking place on 24 - 25 September in Gothenburg, Sweden.

We are currently shaping the agenda for your! Stay tuned! 

Sincerely,

The Co-Chairs

Sabine Hauck, Consultant
Elisabeth Vachette, Sartorius 

SCIENTIFIC PROGRAM PLANNING COMMITTEE

  • Sabine Hauck, Consultant
  • Elisabeth Vachette, Sartorius
  • Andrea Arsiccio, Coriolis
  • Adithya Balasubramanian, ten23 health
  • Bianca Bohrer, PSM
  • Cristiana Campa, GSK 
  • Michael De Felippis, Eli Lilly
  • Sebastian Groel, Daiichi-Sankyo
  • Virginie Le Coent, BioMerieux
  • Julian Lenger, Bayer
  • Yves Mayeresse, GSK
  • Mic McGoldrick, MSD 
  • Maria Papathanasiou, Imperial College London
  • Josh Eaton, PDA
  • Falk Klar, PDA Europe
  • Sabine Hartmann, Manager Programs & Events, PDA Europe

Early Registration

Register by 28 July 2024

Member Price

€ 2.050

GovernmentMember Only

€ 980

Health AuthorityMember Only

€ 980

Early Career ProfessionalMember Only

€ 980

StudentMember Only

€ 980

AcademicMember Only

€ 980

Non-Member

€ 2.350

Standard Registration

Register after 28 July 2024

Member Price

€ 2.250

GovernmentMember Only

€ 1.080

Health AuthorityMember Only

€ 1.080

Early Career ProfessionalMember Only

€ 1.080

StudentMember Only

€ 1.080

AcademicMember Only

€ 1.080

Non-Member

€ 2.550

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. [email protected]

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 [email protected] 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.

Day 1

Tuesday, 24 September 2024

09:00

Welcoming
Falk Klar, PDA
Sabine Hauck, Consultant
Elisabeth Vachette, Sartorius

09:15 - 13:00 I Opening Plenary: Addressing Patients Needs  
Moderators: Elisabeth Vachette, Sartorius

Patient Perspective
Speaker to be announced

Title to be Announced
Paul Ehrlich Institut

Title to be Announced
Medical Products Agency Sweden

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

Developing Patient Centric Specification for Commercial Biologics: Real World Case Studies
Bristol-Meyers Squibb

Plenary Discussion

12:25 - 13:40 | Lunch Break, Poster Session & Exhibition

13:10 - 13:40 | Guided Poster Walk - Engage with our Poster Presenters in our Exhibition Hall
Moderator: to be announced

Concurrent Sessions

13:40 - 15:25 I Session 1 Track A: Processes for New Entities in Freeze-Drying
Moderator: Julian Lenger, Bayer

Developments in Line and Offline Process Testing for Biologicals
MHRA

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

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

Q&A, Discussion

13:40 - 15:25 I Session 1 Track B: CMC Strategies for Vaccines Biomanufacturing
Moderator: Cristiana Campa, GSK

Vaccines Interest Group Session - Our 2024 Journey!
Merck, Sharp & Dohme

Patient-Centric Development for Vaccines
GSK

Applying Prior Knowledge and Patient-Centric-Based Considerations to Specification Setting
Johnson & Johnson

Q&A, Discussion

15:25 - 15:55 | Coffee Break, Poster Session & Exhibition

15:55 - 17:40 I Session 2 Track A: Opportunities for Vaccine Access
Moderator: Mic McGoldrick, MSD

Title to be Announced
EFPIA/VE

Building health emergency preparedness by harnessing the potential of Vaccine Platforms
CEPI

Regulatory Global Convergence, Harmonization, and Reliance
Merck Sharp & Dohme

Q&A, Discussion

15:55 - 17:40 I Session 2 Track B: Innovation in Biomanufacturing
Moderator: Michael De Felippis, Eli Lilly

Cell-Free Manufacturing of Proteins
Invitris GmbH

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

Polysorbate Control Strategies in Biopharmaceuticals
Clear Solutions Laboratories

Q&A, Discussion

17:40 | End of Conference Day 1 and Networking Event

Day 2

Wednesday, 25 September 2025

Concurrent Sessions

09:00 - 10:45 I Session 3 Track A: Digital Tools Shaping Future Biomanufacturing
Moderator: Adithya Balasubramanian, ten23 health

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

A Regulatory Framework Enabling Digital Innovation in Manufacturing
GSK

Accelerated Process Development Using End-to-End Digital Twins
Körber Pharma

Q&A, Discussion

09:00 - 10:45 I Session 3 Track B: Future Techniques in Freeze-Drying
Moderator: Sebastian Groel, Daiichi-Sankyo

Title to be Announced
HOF Sonderanlagenbau GmbH & Roche

Continuous and Controlled Lyophilization of mRNA-LNPs Based Formulations
RheaVita

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

Q&A, Discussion

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

10:50 - 12:10 I Session 4 Track A: Fill & Finish Processing 
Moderator: Yves Mayeresse, GSK

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

VHP Uptake of Manufacturing Tubing Used for Aseptic Fill-Finish Processes of Biopharmaceutical Drug Products
ten23 health

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
Kindeva & Innerspace

Q&A, Discussion

10:50 - 12:10 I Session 4 Track B: Sustainability
Moderator: Virginie Le Coent, BioMerieux

Title to be Announced
EDQM

Enhancing Sustainability ESG Scores in BioManufacturing
BioMerieux

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

Q&A, Discussion

12:35 - 13:35 | Lunch Break, Poster Session & Exhibition

13:35 - 17:00 I Closing Session: Innovative Regulatory Strategies for a Globalized World
Moderators: Sabine Hauck, Consultant

Interactive Questionnaire

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

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

14:35 - 15:05 | Coffee Break, Poster Session & Exhibition

15:05 - 15:10 | Passport Raffle

Title to be Announced
U.S. FDA

Title to be Announced   
EMA

Planery Discussion 
Join our Discussion with Experts from Industry and Regulatory 

Co - Chairs Conference Summary
Sabine Hauck, Consultant
Elisabeth Vachette, Sartorius

Closing Remarks & Farewell
Falk Klar, PDA Europe

17:00 | End of Conference

Agenda is subject to change.

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.

PDA recommends the reservation at the following hotel

Elite Park Avenue Hotel 
Kungsportsavenyn 36 - 38
411 36 Gothenburg,
Sweden

PDA Europe has reserved a limited number of rooms until the 20th of July 2024.

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

How to Get Here
By Air

Airport buses travel to and from Landvetter Airport (appox. 20 min. journey) stopping at Gothenburg Berzeliigatan. They run directly between these stops.

Travel and Exclusive Discount Information
Special Lufthansa Group Airlines Fares
Special Lufthansa Group Airlines Fares

The Lufthansa Group airlines bring people together – every day, all around the world.The global route network of Austrian Airlines, Lufthansa, SWISS, Brussels Airlines and Eurowings offers optimal connection and combination options, so you will benefit from quick and direct flights to the event.

You will reach the booking platform via this link https://www.lufthansa.com/de/en/meetings-and-events-delegates and with the event code DEAPILQ. The reduced fares are automatically displayed.

Note: Please enable pop-ups permanently in your browser while booking, otherwise the window in the booking platform will not open.

Of course, you can also book through your IATA travel agency. The travel agency can request the ticketing instructions by sending an email to [email protected], stating the event code DEAPILQ.

Book Flight
Special Deutsche Bahn Train Fares
Deutsche Bahn Train logo

Get there relaxed – get there sustainable – travel CO2-free. Your Event Ticket at a fixed price throughout Germany. From any Deutsche Bahn station to our event, with the City-Ticket included.

Event Ticket one-way and specific train (subject to availability):

  • 1st class 89,90€ (seat reservation incl.)
  • 2nd class 55,90€

Event Ticket one-way and fully flexible:

  • 1st class 112,90€ (seat reservation incl.)
  • 2nd class 77,90€

Book online now and get the lowest price for your preferred route – guaranteed. For technical questions, please contact the service number +49 (0) 30 58 60 20 901. Create the perfect start for your sustainable event: Make active use of your journey to work or just relax and enjoy the high-speed travel experience – with 100% renewable power on regional and long-distance services.

Book Train
Area Attractions

Elite Park Avenue Hotel is located within walking distance from Liseberg amusement park and the Swedish Exhibition & Congress Centre. Theatres, concerts and the Gothenburg Museum of Art is a short walk from the hotel. Along Avenyn are parks, boutiques, shopping malls, and cozy cafés.

Enjoy the well-equipped gym and relaxation area with saunas and a smaller cooling pool. We can also show you our favourite running routes around Gothenburg.