Cell bank testing
An integral part of biologics testing and manufacturing procedures, starting material testing is a critical quality control step in biopharmaceutical manufacturing ensuring the safety, consistency, and reliability of cell lines and cell banks (MCB, WCB, EOPCB) used to produce therapeutic products.
Cell line testing typically includes biosafety testing and characterization which together define a quality control framework addressing regulatory guidelines with the aim of ensuring the quality of the manufactured drug product.
Clean Cells, a GMP-licensed CDMO and CRO with extensive research backgrounds on hundreds of cell models, has perfected quality control services to ensure the highest-level of safety and quality to cell lines used in all types of biopharmaceutical processes. Together with cell banking services, they form a one-stop-shop portfolio of cGMP solutions from initial cell seed characterization to release of fully-validated Master and Working Cell Banks.
Assays considered for cell bank quality control
Clean Cells offers a number of assays to guarantee both safety and potency of cells:
- Sterility, endotoxin, mycobacteria and mycoplasma testing: ensure the absence of microbial contaminants.
- Virus Testing: demonstrates freedom from adventitious agents by cell culture or qPCR assays. Extent of testing is defined based on a risk-assessment.
- Cell Line Authentication and genetic stability: confirms the species of origin, the identity of the cell line and the absence of genetic instability.
- Cell viability and growth testings: confirms cell banks are potent for their intended use.
- Functional testing: depending on the biopharmaceutical being manufactured, additional functional tests may be conducted.
Our Quality Management System, extensively audited by tens of clients each year and regularly inspected by French authorities and FDA, ensures detailed records of all control procedures, results, and relevant information are documented to provide a comprehensive profile of the cell bank.
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