GMP Manufacturing facilities
- 4 GMP Fermentation suites (80-2200L)
- 3 GMP Purification suites
- 1 GMP 0.2 μm filtration suite
- Classified clean rooms
- Full traceability
- QA and QP release
All GMP material is produced in accordance to FDA 21 CFR Part 210 & 211, EU 2003/94/EC, Eudralex Vol 4, and relevant ICH; the regulatory requirements for sterile injectable products intended for human clinical trials and commercialization.