Viral Gene Therapy cGMP Production
Access cGMP facilities that are equipped to manufacture across a variety of scales from early phase to commercialization.
Our global cGMP capacity supports the movement of programs from our process development laboratories into manufacture, including drug substance and drug product testing as a single comprehensive supplier. It also provides you with options for the direct transfer of programs into our network.
Access Our Experience
With us, you gain access to our global network of highly skilled teams dedicated to earning your trust with unprecedented delivery. Some of our areas of expertise include:
- cGMP production of clinical and commercial products
- Over 2,000 batches completed and dispositioned
- Integrated streamlined CMC services
- All aspects of testing and characterization in support of IND/IMPD or BLA/MAA applications
- More than 20 INDs supported for viral gene therapies
- Quality and regulatory oversight on your route to commercialization
Complete Viral Gene Therapy cGMP Manufacturing Capabilities
Regardless of scale or phase, our flexible cGMP facilities provide the following services:
- cGMP cell and viral banking
- In-house GMP production of plasmids
- GMP adherent: Hyperstacks and micro-carrier technologies (up to 200 L)
- GMP suspension: Multiple single-use bioreactors with multiplexing options (10 L, 50 L, 200 L, 500 L and 2000 L)
- Global locations providing convenience and flexibility
- Drug product filling (vials, pre-filled syringes and cartridges)
