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.

Our capabilities

  • 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

Expansion Systems

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)

Cell & Virus Banking Experts

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Cell & Virus Banking project

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SERVICE OFFERING

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.

Blog

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.