Cell & Virus Banking
Manufacture of high-quality GMP and non-GMP cell and virus banks in multiple expansion formats and sizes- as critical starting materials vital to your production process and timeline management.
RELIABLE STARTING MATERIAL GENERATION
Successful manufacture and release time after time
Establishing high-quality GMP master and working starting materials are critical to ongoing production of clinical and commercial product supply. Vibalogics employs decades of experience and robust practices sourcing chemically-defined and animal-derived raw materials for cell culture applications, establishment of detailed batch manufacturing records, and well-trained operators. Full ICH cell and viral bank characterization services are offered in compliance with regulatory guidance, and assisted in partnership with quality-audited and approved contract laboratories.
Cell line experience
Virotherapy production commonly utilizes human, simian, and insect-derived cell substrates for efficient expression or propagation of viruses and vectors. Our cell line experience includes: A549, HEK293/T, HeLa, MRC-5, Vero, SF9, MDCK, CAP, and more. Primary tissues can also be established for use including chick embryo fibroblast (CEFs) derived from SPF eggs.
Virus rescue & seed bank establishment
Master and working virus seed banks serve primary infection stock or as helper viruses in virotherapy production. A part of Vibalogics virus banking service, is capability for de novo generation and recovery of infectious virous from plasmid-based systems (virus rescue), as well as perform genetic characterization and seed assessment for preliminary infectivity, titer, and more.
- GMO/BSL-2 facilities
- Client-dedicated ISO 5 cleanrooms (Grade A-C background)
- 50-1500+ vial bank size for
- Manual and semi-automated vial fill
- Short-and Long-term storage
- Templated batch records and documentation
- Raw material release demonstrating quality, compliance and traceability
- ICH Guidelines for characterization and stability
Production of cell and virus seed banks in common adherent and suspension culture technologies include:
- T-flasks or shake flasks
- Multi-layered flasks (e.g. HYPERFlask®)
- Roller bottles
- Cell stacks and factories
- Small-scale bioreactor (e.g. rocker system)
- Large-scale bioreactor (up to 50L for purified virus banks)
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.