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
Odum,
CPIP,
Head of Design, Technology & Standards, Biologics Engineering,
Sanofi
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