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Key Sessions

Brendan Hughes

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
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
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
A Representative from IDBS
10:00 - 10:45 45 mins
Morning Coffee
10:45 - 11:15 30 mins
NGS and Virus Detection - Applications and Strategies
Next generation sequencing efforts at CBER
  • pending final confirmation Arifa Khan - Supervisory Microbiologist, FDA
11:15 - 11:45 30 mins
NGS and Virus Detection - Applications and Strategies
Testing strategies for adventitious agents: impact of NGS introduction
  • Laurent Mallet - Senior Director, Product Conception and Development, Sanofi-Pasteur
11:45 - 12:15 30 mins
NGS and Virus Detection - Applications and Strategies
Spotlight Presentation - Charles River
12:15 - 13:30 75 mins
Lunch and Networking
13:30 - 14:00 30 mins
Info
NGS and Virus Detection - Applications and Strategies
Rapid Methods for Adventitious Virus Detection and Sterility Assurance: How can we achieve broad adoption?
  • Cristina Barbirato - Senior Scientist - Scientific and Regulatory Expertise of BQC Biopharma,, Merck MSD

As part of the BioPhorum Technology Roadmapping Phorum, Project “RAVnS” is focused on Rapid methods for Adventitious Virus Detection and Sterility Assurance.

This project contributes to the goals of the BioPhorum 1st edition BioManufacturing Technology Roadmap to reduce production lead time by reducing product lot release times from weeks with current methods to days with innovative methods.

Team members consist of industry professionals from over 10 biopharmaceutical companies who are all interested in driving the adoption of potential solutions.


To collate information on current testing regimes and interest/activities in rapid innovative methods surveys were conducted. Questions included identifying the main point of dissatisfaction with current methods are, barriers to adoption, and what activities would be useful in driving adoption of regulatory compliant release testing. Because the expectation is that methods will continue to evolve, the survey purposely did not focus on technology platforms, but rather focused on generic points to consider for implementing new methods which will serve as the basis for today’s and future methods.


Participants of the survey were identified and selected by the group to be subject matter experts in this topic. Comments and results from the survey are presented herein.

14:00 - 14:30 30 mins
NGS and Virus Detection - Applications and Strategies
Next-Generation Sequencing vs Traditional Methods: Considerations and Proof of Concept Data for the Development of a Next-Generation Sequencing Method for Adventitious Virus Detection
  • Maria Bednar - Scientist I, AT Virology, Biogen, USA
14:30 - 15:00 30 mins
Risk Assessment, Facility Design and Segregation
Viral Segregation Strategy for New Facility Designs
  • Bonnie Shum - Senior Engineer, Global Biologics Manufacturing Sciences and Technology (MSAT), Genentech
15:00 - 15:30 30 mins
Risk Assessment, Facility Design and Segregation
Spotlight Presentation - SGS
15:30 - 16:00 30 mins
Afternoon Coffee
16:00 - 16:30 30 mins
Emerging and Existing Viruses of Concern
Circulation of HEV in Europe – implications for blood / plasma product safety
  • Maria Farcet - Scientist, Global Pathogen Safety, Shire
16:30 - 17:00 30 mins
Emerging and Existing Viruses of Concern
Viral Clearance Testing in a Continuous Manufacturing Process
  • Konstantin Zoeller - Fellow, Scientific leader, Gene Therapy, Novartis
17:00 - 17:05 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 - 16:00

Afternoon Coffee

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Showing of Streams
17:00 - 17:05
End of Day Three

End of Day Three

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