Drug Substance & Drug Product
Preclinical-through-commercial virotherapy manufacturing services
Virotherapy manufacturing is a complex, multistage process requiring a CDMO that understands the intricacy of viral production. Our service starts with the establishment of cell & virus seed banks, technical transfer or development of the production process, establishing necessary analytical methods for characterization and release, and completing a campaign with fully-released GMP drug substance and drug product. Vibalogics’ end-to-end service model allows for reduced development timelines by shortening vendor handoffs, while strengthening client-vendor working relationships, ultimately mitigating risks and creating security of the product supply chain.
Manufacturing Services
GMO/BSL-2 facilities for live viruses and vectors
ISO 5/7 cleanrooms (Grade B/C)
Manufactured, tested, filled drug substance & drug product
Single-use-systems (SUS) minimizing contamination
Suspension technology (50-2000L stir-tank-bioreactors)
Adherent technology (microcarriers, cell stacks, roller bottles, rocker systems, and more)
Aseptic process validation (Non-filterable products)
Real-time observation (Person in Plant)
