GMP Cell Banking
The establishment of regulatory-compliant, robust, and traceable cell banks is critical for GMP-grade AAV production. PackGene provides reliable and economic cell bank construction that usually be submitted for testing. The condition of the cell bank affects the quality control and testing methods for gene therapy products. PackGene provides high quality cell bank screening and construction services to meet your cell bank needs from pilot to large scale production and multi-level cell bank delivery. We also offer flexible and effective high-yield cell line screening and library development solutions and methods for specific customer needs.
|Banking Service||Function & Purpose||e.g|
|Cells||Master Cell Banking||Fully characterized, used for establishment of working cell banks||AAV-293 Cell|
|Working Cell Banking||Used for expansion and production of final product|
Setup Strategy for Cell Banks
Banking of master and working cell banks (MCB, WCB) is performed in a separate and dedicated GMP area designed for these activities. Clients may provide their cell lines for banking or may choose PackGene to create in-house cell lines for the establishment of project-specific cell banks. PackGene has extensive experience and dedication to cell lines for both adherent and suspension HEK293/293T cell lines, and is able to perform high yield screening and identification of candidate cell lines to ensure that high yield cell lines are obtained prior to cell banking.
Master Cell bank (MCB) and Working Cell Bank（WCB）
Cell banks for AAV gene therapy ensures the quality and consistency of the production lifetime of a biological product. Cell banking involves a two-tiered approach that preserves the integrity of the original therapeutic producing cells. A master cell bank can be divided into dozens of working cell banks to ensure the stability of cell passages to maintain the integrity of the original cells. A MCB is derived from a single clone that is expanded and extensively characterized for use in future production. A WCB is derived from the MCB and is commonly used for specific drug fast service production.
Production of Final Cells
The purpose of the production final generation cell assay is to confirm their suitability throughout the production process and whether the cells are mutated or produce carcinogenic substances. Cells are resuscitated and passaged from the working cell bank according to the production process route, transferred to the bioreactor for passaged digestion, cultured according to the proposed process, and then digested for lyophilization or sent for testing at the end of bioreactor production. The generation of cell resuscitation and passaging methods are carried out according to the production process SOP.
Cell bank/end-of-production cell validation
According to the regulatory requirements on the pharmacopoeia, the establishment of cell banks should follow the following criteria for testing, including and 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
- Cell identification
- Genetic stability
- Identification, integrity and copy number of the introduced sequence
- Endogenous/exogenous viral factors
- Sterility testing
- Mycoplasma detection
- Fungus detection
- Spiroplasma detection