Master Cell Bank Manufacturing

Biologicals such as monoclonal antibodies and recombinant proteins are produced in cultured cell lines from humans, lower mammals, insects, and bacteria. These therapeutic producing cells are typically created through a process that involves:

• Gene transfection or transformation
• Screening for expression
• Cell expansion and characterization

While in culture, these cells must be passaged regularly increasing the chance of genetic alteration, contamination, or loss of expression constructs as the cells divide. Thus, for optimal drug production, it is critical that cells are passaged as few times as possible and that the original high producing clone is not lost or altered.

A Master Cell Bank (MCB) is produced from the original therapeutic-producing cell line. It is cryopreserved in multiple vials to prevent genetic variation and potential contamination by eliminating the total number of times a cell line is passaged or handled during the manufacturing process.

Before regulatory submission, these cell banks must be well characterized and tested for contaminants such as bacteria, fungi, and mycoplasmas. BioReliance offers these services including cell line characterization, and genetic stability.