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2020 ISPE Continuous Manufacturing Virtual Workshop


Implementation Approaches for Large Molecule


Jun 24, 2020 12:00am ‐ Sep 11, 2020 6:08am

Description

Implementation Approaches for Large Molecule

Implementation Approaches for Large Molecule Continuous Manufacturing This session will focus on the integrated and continuous biomanufacturing process applied in the production of large molecules with experience shared by Sanofi, Pfizer and BI. Several areas will be discussed including leveraging the at-scale data to support comparability studies, as well as pre PPQ campaigns, and lifecycle process validation considerations.

  • Lifecycle Process Validation Considerations for Large Molecule Continuous Manufacturing
    Katherine Giacoletti, Partner
    SynoloStats LLC  
  • Leveraging ICB Technology for Novel Approaches to Process Performance Qualification
    Kevin Brower, Head of Purification Development
    US Sanofi
  • Development of an Integrated Manufacturing Process: The iSKID™
    Michael Jankowski, associate Research Fellow, Analytical R&D
    Pfizer Biotx Pharm Sci

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