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JOINN Biologics
Master Cell Banking
Master Cell Banks (MCB) are needed for cell lines used to produce products in manufacturing campaigns.
A MCB is generated from a research cell bank (RCB) when cell line development is completed. Cells from a RCB are thawed and expanded, and when cell counts reach the desired number, a MCB is prepared and stored in a LN2 freezer.
Samples of the MCB are taken for characterization, stability and safety studies. At JOINN Bio, tests for MCB may include the following to ensure quality of our Master Cell Bank:
Master Cell Banking Characterization
| Category | Tests |
|---|---|
| Confirmation and stability | Nucleic Acid Sequencing Southern Blot For Genomic DNA Gene Copy Number Determination Restriction Endonuclease Analysis |
| Safety | Sterility Mycoplasma Bacteriostasis Electron Microscopy In Vitro Viral Assay In Vivo Viral Assay Viral Particle Testing Antibody Production Assays |
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