Process Development
This plan encompasses all aspects of product manufacturing and testing, from the raw material inputs to the final product configuration and quality control methods.
- Process modeling for streamlining, scalability, cost of goods (COGs) and capacity modeling
- Small and large scale adherent cell culture systems
- Suspension based cell culture systems including wave bag, microcarrier, and bioreactor platforms
- Closed systems and disposables development
- Scale up and scale out (Allo/Auto)
- Cell banking strategy
- Media optimization and feed strategies
- Closed system volume reduction and washing technologies
- Aseptic fill and finish systems
- Cryopreservation development and optimization
- PD with NCLi results in
- A process that is safe, robust, and reproducible
- Batch records and SOPs that are GCTP/GMP ready
- A bill of materials with appropriate quality
- Methods for product quality control
- GCTP ： Good Gene, Cellular, and Tissue-based Products Manufacturing Practice
- GMP ： Good Manufacturing Practice
- CDMO ： Contract Development and Manufacturing Organization