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Sorvall RC 12BP Plus Large Capacity Centrifuge Product Literature

What is the Master Cell Bank and Production Lot? Product FAQ

Answer

When a cell line is to be used for many manufacturing cycles, a two-tiered cell banking system consisting of a master cell bank (MCB) and a working cell bank (WCB) is used.

A cell line is established from a single clone and this cell line is used to make the MCB. This MCB is characterized and extensively tested for contaminants such as bacteria, fungi, mycoplasma and viruses. Cells from the MCB are expanded to form the WCB. Each lot of cells is tested for cell growth and viability post-recovery from cryopreservation.

The establishment of cell banks for newly developed cell lines is critical to the successful development of many biological products. The cell bank system assures that the cell line is preserved, its integrity is maintained, and a sufficient supply is readily available. A well-characterized cell bank system for production of biologicals will allow for a consistent source of production cells throughout the life of the product. This method is used in many biotechnology products, which involve the use of cell lines of animal or human origin, and are at risk of viral and microbial contamination.

Here is an example of typical progression from R&D cultures to Production: R&D provides several R&D Master vials to Manufacturing. A Production Master Bank is generated (via 3-4 passages) and qualified via viability and mycoplasma testing. Most cell lines also are qualified via functional expression assay. The initial Production Lot is propagated from one vial of the Master Bank via 3-4 passages (normally taking 1-2 weeks total production time). The Production Lot is qualified via viability and sometimes, functionality. This results in a cell product that is less than 10 passages away from the original R&D clone. In most cases, no viral or mycoplasma tests are done to test the final production lot. ALL Master Cell Banks and Production Lots are stored in liquid nitrogen, therefore maximizing viability and minimizing variability between Master and Production Lots.

Answer Id:: E4231

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  • Authors: Conconi MT, Baiguera S, Guidolin D, Furlan C, Menti AM, Vigolo S, Belloni AS, Parnigotto PP, Nussdorfer GG
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