Virtual Presentation: A-Cell: Best Practices for the Manufacture of Cell Therapies
Time: 11:20 am
day: Day One
Details:
- Establishing Quality Target Product Profile and Critical Quality Attributes early are critical to managing comparability across products and process changes during development
- Risk and criticality assessment tools are used throughout product development to establish processing operations, design space, and control strategy to ensure the process delivers a quality product in a reproducible process
- A comparability plan to introduce manufacturing changes should be developed as early as possible in product development, preferably before a phase 1 trial
- The acceptability of comparability depends on the knowledge of the product, availability of well-defined CQAs that are informative for product safety and efficacy, and timing of when the major change is introduced in the product development cycle
