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

Moderator(s):

• Liuquan (Lucy) Chang, PhD, Executive Director, Global Regulatory CMC Biologics, Merck & Co., Inc.

Speaker(s):

• Katherine Giacoletti, Partner, SynoloStats LLC
• Kevin Brower, PhD, Head of Purification Development-US, Sanofi
• Michael Jankowski, Senior Principal Scientist, Analytical Research & Development, Pfizer Biotx Pharm Sci