A-Cell: Best Practices for the Manufacture of Cell-Based Therapies
Time: 4:30 pm
day: Day Two
- Establishing Quality Target Product Profile and Critical Quality Attributes early are critical to managing comparability across products and process changes during development.
- A systematic, risk-based approach to product development is key to facilitating efficient clinical development and marketing authorization. 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.
- An integrated and iterative strategy that incorporates product and process understanding, control strategy, and correlative analyses with clinical outcomes should provide increasing CQA knowledge and experience throughout the product life cycle, leading to greater assurance of product quality.