Forecyte’s comprehensive CDMO service covers the life cycle from research to clinical to commercial:
- Early-stage project services: vector construction, research-grade material production
- GMP clinical manufacturing: tech transfer, process development/optimization, and GMP clinical manufacturing
- Analytical services: analytical method development, qualification, and lot release and stability testing
- Commercial manufacturing capability
- CMC regulatory consulting and filing
- Wide range of products: Plasmids, Viral Vectors, Cell Products, and mRNA
Forecyte’s service is based on the broad expertise of its technical team and its state-of-the-art capabilities:
- Decades of CGT CMC product development and GMP manufacturing experience
- Strong technical team with decades of hands-on working experience at world-renowned CGT CDMO companies
- Established Quality System compliant with International Regulations
- Extensive regulatory filing experience; filed more than a dozen IND/CTA and a BLA
- Facilities established in US and China, enabling multi-national regulatory filings and studies