Description

Analytics Considerations for Continuous Manufacturing

Analytics Considerations for Continuous Manufacturing This session will be a series of presentations related to analytics and release assays critical to successful implementation of CM. The session will include perspectives on emerging approaches for assessment of quality attributes, on release testing, and on the importance of process control and PAT.

• Quality Considerations for the Multi-Attribute Method (MAM)
  Sarah Rogstad, Staff Fellow, Chemist
  FDA
• Modern Microbiological Monitoring of Continuous Processing
  Cheryl Essex, Head of Microbiological Control for Biologic Drugs
  Sanofi
• Integrating Analysis with Process Control for the Continuous Bioprocessing: Extending the Lifecycle Concept to Process Analytical Technologies
  Jose C. Menezes, PhD, President and CEO
  4Tune Engineering Ltd

Moderator(s):

• Jeffery N. Odum, CPIP, VP of Biopharma Life Sciences, Exyte

Speaker(s):

• Sarah Rogstad, PhD, Staff Fellow, Chemist, Office of Testing & Research, CDER/FDA
• Cheryl Essex, Head of Microbiological Control for Biologic Drugs, Sanofi
• José Menezes, PhD, CEO, 4Tune Engineering Ltd