Designing a Gene Therapy CMC Architecture for the Full Product Lifecycle
Process Development & Contract Services Decision Making
This guide helps give gene therapy innovators a high-level perspective on the process development and contract services selection decisions to be made throughout the phases of development.
- Speed to clinic or speed to market—process development ramifications
- When should a CMC program begin?
- Contract service organizations needed throughout your product’s development phases
- Contract services partner selection considerations
- Questions for a potential CDMO
- Partnering with manufacturing services partners to optimize processes and address challenges