Crafting

Genetically stabilizing living cells has been considered an indispensable stage in reproducible production and continuity in the fermentation industry. Recombinant DNA technology has been made possible by isolating and amplifying genes or DNA fragments and inserting them with precision into microbial cells. E. coli has been in favor in industrial processes due to their well-elucidated genetic background. Our cGMP-compliant cell banking systems are set up to assure that a uniform population of cells is preserved, their integrity is maintained, and a sufficient supply of material is accessible for the life of the product.

Our microbial cell bank generation team has a wealth of experience in manufacturing E. coli cell banks to the highest standards. Microbial cell bank generation services are conducted under appropriate, controlled conditions. We have dedicated, fully-equipped CGMP-compliant suites with the capability to produce hundred vials of cell bank.

In many manufacturing cycles with E. coli cells, a two-tiered cell banking system consisting of a master cell bank (MCB) and a working cell bank (WCB) is recommended. The MCB is established from a single clone and must be characterized. The WCB is formed from the expanded MCB, which is characterized for cell viability prior to use in the manufacturing process. We can provide Research Cell Banks (RCB), Master Cell Banks (MCB), and Working Cell Banks (WBC).

 
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