Drug Substance & Drug Product
Decades of experience in GMP and non-GMP manufacture of live viruses and vectors including oncolytic viruses, gene therapies, and vaccines for use across global regulatory environments.
VIRUS AND VECTOR EXPERTISE
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.
- 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)
Cell & Tissue Substrates
Our capabilities extend to multiple platforms capable of meeting the requirements for breadth of viral production processes. We have decades of experience in the development and production of both cell-based (suspension and adherent) and egg-propogated viruses.
Suspension Culture: We have expertise working with suspension cultures of industry-dominant cell lines such as HEK293, HeLa, A549, CAP, and Sf9 cells. Our suspension culture platform and expert team provide customers with a highly customizable way of making virotherapy products.
Adherent Culture: Our expertise additionally extends to adherent cell culture experience covering most production relevant cell lines, from VERO, HEK293, A549, MRC-5, MDCK, through to BHK21, CEFs and MRC-5.
SPF Egg-based: Thanks to our early origins in the animal vaccine market, Vibalogics is one of the few CDMOs to offer egg-based virus manufacturing using Specific Pathogen Free (SPF) eggs for live products. We are highly experienced in aseptic validation of these processes for large-diameter viruses, which cannot be sterile-filtered (e.g. poxviruses, VSV, measles).
Looking for something different?
Vibalogics can assist you through a comprehensive service portfolio – ensuring success of your virotherapy, beginning with process development and technical transfer feasibility, through cGMP production and validation.
QC Release & Stability Testing
The Advantage of Engaging Your CDMO Early
One of the key things that I have learned from my many years in the biopharma market is that it is not only important to work with a trusted contract development and manufacturing organization (CDMO) to develop and commercialize your product, but that it is vital to reach out and engage with your partner early as well.