GMP Cell Banking
The establishment of regulatory-compliant, robust, and traceable cell banks is critical for GMP AAV production. PackGene provide reliable and economic cell banking that usually be submitted for testing. The cell bank may determine which types of quality control and quality assurance assays must be performed for final product release. PackGene has the experience to quality you need for GMP banking, including the creation of master and working banks. We offer flexible cell banking options and methods for specific needs.
|Banking Service||Function & Purpose||e.g|
|Cells||Master Cell Banking||Fully characterized, used to establish working cell banks||AAV-293 Cell|
|Working Cell Banking||Used for expansion and production of final product|
Creation Strategy for Cell Banks
Banking of master and working cell banks (MCB, WCB) are performed in a separate and dedicated GMP area designed for these activities. Clients may provide their own cell lines for banking or may choose PackGene to create in-house cell lines for the establishment of project-specific cell banks. PackGene has experience and dedication to cell lines for both adherent and suspension HEK293/293T cell lines.
Master Cell bank (MCB) and Working Cell Bank（WCB）
Cell banking for gene therapy ensures quality and consistency of the production lifetime of a biologic product. Cell banking involves a two-tiered approach that preserves the integrity of the original therapeutic producing 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 used for specific drug product production.
Specifications Assay for Cell Banks
According to the regulations of Pharmacopoeia, the cell banks are recommended to test the below specifications, including but not limited to:
- 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