Formed in 2018, Cell & Gene Therapy (C>) supports the quest for better and faster development of cell and gene therapies. In this collaboration, we connect drug development and contract manufacturing organizations with the aim of ensuring harmonization and alignment around issues such as potency assays, phase-appropriate guidance for critical quality attributes, operator safety, regulatory guidelines, and C>-specific validation issues, as well as working towards resolving the current challenges to commercializing C> products.
The business of cell and gene therapy is as diverse as the patients which it serves and for that there is no one size fits all solution.
C> members have identified six pre-competitive common interest challenges, addressing these challenges will help to avoid multiple industry solutions
- High-level analytics
- Regulatory strategy
- Commercialization
- Validation
- Raw material sourcing and supply
- Environmental health and safety
