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Key Sessions

Tony D'Amore, PhD, MBA

Examining the Advances and Challenges in Vaccine Development and Manufacture

Sanofi Pasteur

Brendan Hughes

Keynote: Operating in a Disruptive Bioprocessing Landscape - Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity

BMS

08:20 - 08:30 10 mins
Chairperson's Opening Remarks
08:30 - 09:00 30 mins
Info
Plenary Session
Examining the Advances and Challenges in Vaccine Development and Manufacture
  • Tony D'Amore, PhD, MBA - Vice President, Product Research and Development, Sanofi Pasteur

This presentation will review the constraints and complexities of vaccine product development and manufacture.  With this increasing complexity, higher costs and competition; evolutions in bioprocess and analytical technologies to accelerate and overcome these challenges are reviewed.  Strategies to leverage innovation and technology for rapid product development and increasing productivity are discussed.  Specific examples are provided, as well as emerging technologies, such as continuous manufacture.

09:00 - 09:30 30 mins
Plenary Session
Keynote: Operating in a Disruptive Bioprocessing Landscape - Next Generation Bioprocessing Technologies, Facility Design and Products to Improve Process Productivity and Increase Capacity
  • Brendan Hughes - Vice President, MS&T, BMS
09:30 - 10:00 30 mins
Plenary Session
Plenary Talk Three – IDBS
10:00 - 10:45 45 mins
Morning Coffee
10:45 - 11:15 30 mins
Process Analytical Technologies – On-line and In-line Monitoring
How Can We Reflect The Dynamic Nature Of Process Operation In The Design Space Representation?
  • Moritz von Stosch - Senior Manager Fermentation, GlaxoSmithKline
11:15 - 11:45 30 mins
Info
Process Analytical Technologies – On-line and In-line Monitoring
Scale-down cell culture models for process characterization in vaccine manufacturing
  • Ilse Remmers - Scientist USP, Janssen vaccines & Prevention

Janssen Vaccines uses a perfusion-based PER.C6® cell culture process for Adenovirus vaccine production. This process has been successfully used to produce early phase clinical trial material for various vaccine development programs and is now moving on towards late stage development. To support elaborate process characterization studies, a representative reduced scale model is needed. In this presentation we highlight our approach and challenges towards scaling-down our full scale high-cell density perfusion process.

11:45 - 12:15 30 mins
Process Analytical Technologies – On-line and In-line Monitoring
Spotlight Presentation – Sartorius
12:15 - 13:30 75 mins
Lunch and Networking
13:30 - 14:00 30 mins
Info
Process Analytical Technologies – On-line and In-line Monitoring
Analytics and real time product release – regulatory perspective
  • Santosh K Nanda - Interdisciplinary Scientist, FDA/CBER, USA (awaiting final confirmation)
  • What are the regulatory perspectives on real time release testing for vaccines?
  • Control strategies,
  • CQA’s
  • QbD
14:00 - 14:30 30 mins
Process Analytical Technologies – On-line and In-line Monitoring
Spotlight Presentation – BioRad
14:30 - 15:00 30 mins
Modern Methods for the Full Characterisation of Vaccines
Discussion Panel: Analytics in Vaccine Development
15:00 - 15:15 15 mins
Modern Methods for the Full Characterisation of Vaccines
Spotlight Presentation – Expres2ion Bio (15 mins)
15:30 - 16:15 45 mins
Afternoon Coffee
16:15 - 16:45 30 mins
Assay Analysis for Release Testing and Mode of Action
A presentation from GSK Vaccines - pending final confirmation
  • Helge Abrecht - Expert Scientist, Cell & Viral Drug Substance, GSK Vaccines, Belgium
16:45 - 16:50 5 mins
End of Day Three
08:20 - 08:30

Chairperson's Opening Remarks

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Showing of Streams
10:00 - 10:45

Morning Coffee

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Showing of Streams
12:15 - 13:30

Lunch and Networking

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Showing of Streams
Showing of Streams
15:30 - 16:15

Afternoon Coffee

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Showing of Streams
16:45 - 16:50
End of Day Three

End of Day Three

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