Associate Director Arcellx Smithsburg, Maryland, United States
Process Characterization study should encompass a well though out Process Validation Plan which will include the following: a. Robust FMEA b. Small Scale Model Qualification c. Design of experiments using statistical software d. Impurity risk analysis e. Execution of the PC studies (stage 1 screening, stage 2 optimization / augmentation) f. Revise pFMEA g. Finalize Process Control Strategy
Learning Objectives:
understand the complexities of CART Manufacturing and ways to optimize the process to minimize deviations and expedited lot release
How to design Process Characterization Studies
Tools and Tricks to optimize the process characterization
