The characterization and testing of cell banks is a critical component of the control of your biopharmaceutical or biological product. The objective of this testing is to confirm the identity, purity and genetic stability of the cell line. The potential risk of introducing adventitious agents such as bacteria, mycoplasma, fungi or viruses to the biopharmaceutical must be eliminated or minimized. Testing is therefore performed at the level of the master cell bank (MCB), the working cell bank (WCB), and the end-of production (EOPC) or post-production cells.
The Biopharmaceutical Services (BPS) group at Charles River works closely with you to develop cost-effective, scientifically sound, validated testing programs for the characterization of cell banks used to produce biopharmaceutical products. BPS offers cell bank characterization programs that include testing panels designed to detect microbial and viral contaminants and verify cell line identity of the MCBs, WCBs, and EOPC, which are the cells at the limit of in vitro age as designated by the International Conference on Harmonisation (ICH).
The BPS group provides clients with a wealth of experience in cell bank characterization. We concentrate on developing client-focused project designs through discussion of actual needs and provision of dedicated testing programs tailored to the product and its stage of development. While many of the key aspects of testing are similar across the industry, our dedicated programs aim to ensure a timely demonstration of safety that is specific to each cell line.
Suggested Testing for MCBs and EOPC
- Microbial contamination
- Bacteriostasis and fungistasis
- Sterility
- Mycoplasma (cultivable and non-cultivable strains or by PCR)
- Cell line authenticity
- Isoenzyme analysis/DNA fingerprinting and karyology
- Copy number determination
- Restriction map analysis
- DNA/RNA sequencing
- Transmission electron microscopy
- Endogenous retroviruses
- Reverse transcriptase
- Retroviral infectivity assays
- In vitro and in vivo adventitious virus testing
- Antibody production assays
- Mouse (MAP)
- Rat (RAP)
- Hamster (HAP)
- Human viruses by PCR
- Simian viruses
- Bovine and porcine viruses
Suggested Testing for WCBs
- Microbial contamination
- Bacteriostasis and fungistasis
- Sterility
- Mycoplasma (cultivable and non-cultivable strains or by PCR)
- In vitro adventitious virus testing
- Identity
- DNA fingerprinting
- Isoenzyme analysis