Virtual Presentation: A-Cell: Best Practices for the Manufacture of Cell Therapies

Time: 11:20 am
day: Day One


  • 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