The Master Cell Bank (MCB) is one of the first steps in product development and is critical as it will support not only clinical development of the product but also, ultimately, the in-market supply phase, a period that can last decades. Manufacturing and testing of the MCB should be to the highest possible standards. Whilst early clinical development can be performed using the MCB, a Working Cell Bank (WCB) is required for the later stages of development and manufacture. The use of large WCB’s can yield capacity and cost benefits in routine production of products far outweighing the cost of manufacture. A cell banking system is critical in testing of biopharmaceuticals as well as manufacture. Achieving the appropriate level of control and validation of cell based assays is not possible without the establishment of the appropriate detector cell banks.
At BioReliance our state-of-the-art facilities manufacture MCB’s and WCB’s. We have expertise in producing a wide range of cell banks and we offer services for both campaign and non-campaign prokaryotic and eukaryotic cell banking.
Have you fully characterized your cell bank? Click here for more information on our cell bank characterization services.
BioReliance also offers long term storage of cell banks. Download a fact sheet.
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