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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,
Practice Leader: ATMPs & Biologics,
Genesis AEC
Speaker(s):
Sarah
Rogstad,
PhD,
Staff Fellow, Chemist, Office of Testing & Research,
CDER/FDA
Cheryl
Essex,
Head of Microbiological Control for Biologic Drugs,
Sanofi
