GMP Cell Banking

Setup Strategy for Cell Banks

Banking of master and working cell banks (MCB, WCB) is performed in a separate and dedicated GMP facility. PackGene has an experience team capable of preparing and banking cell lines suited for your specific projects. Our team has extensive experience in the preparation of both adherent and suspension HEK293/293T cell lines and will perform high yield screening and identification of candidate cell lines to ensure that high yield cell lines are obtained prior to cell banking. Clients may also provide their own cell lines for banking at PackGene.

Master Cell bank (MCB) and Working Cell Bank (WCB)

PackGene’s cell banks for AAV gene and cell therapy are structured to ensure quality and consistency across the production lifetime of a biological product. We take a two-tiered approach to preserves the integrity of therapeutic producing cells. First, we create a master cell bank that is derived from a single clone and is expanded and extensively characterized for use in future production. This master cell bank can then be divided into dozens of working cell banks to ensure the stability of cell passages while maintaining the stability of the master cell bank. Working cell banks can be used for fast service production without fear of contaminating, or otherwise compromising, the integrity of the master cell bank.

Production of Final Cells

Final deliverable cells are subject to a rigorous assay procedure to confirm the suitability of the cells as well as to rule out detrimental mutations and to ensure that cells do not produce carcinogenic substances.

Cells are resuscitated and passaged from the working cell bank, transferred to the bioreactor for passaged digestion, cultured according agreed upon specifications, and then digested for lyophilization or sent for testing. All cell resuscitation and passaging methods are carried out according to the production process SOP.

Cell Bank/End-of-Production Cell Validation

The establishment of cell banks at PackGene adheres to the regulatory requirements laid out in the pharmacopoeia. Tests include, but are not limited to:

• Identification tests: cell morphology, species, identification, insertion gene identification, large T antigen nucleic acid sequence determination
• Bacterial and fungal tests
• Mycoplasma testing: culture method, DNA fluorescent staining
• Bifidobacterium examination
• Intracellular and extracellular virulence factor examination
• Integrity, copy number determination, transgene sequence determination
• Quantitative tumorigenic examination

Specifications Assay for Cell Banks

In addition to the minimum testing requirements for cell banking several additional testes are recommended in the Pharmacopoeia. PackGene offers these tests as addon services for cell banking, including:

• Cell identification
• Purity
• Genotyping/phenotype
• Genetic stability
• Tumorigenicity/carcinogenicity
• Identification, integrity and copy number of the introduced sequence
• Endogenous/exogenous viral factors
• Sterility testing
• Mycoplasma detection
• Fungus detection
• Spiroplasma detection