Master Cell Banks: Laying The Foundation To Final Product Success

Master cell banks (MCBs) are a critical starting material that lay the foundation for the scale-up and production of cell and gene therapies, biologics, and vaccines. MCBs play a key role in ensuring product consistency and managing risk by eliminating contamination, degradation, extraneous agents, and genetic instability.

Regular testing and characterization of the cells in the MCB is necessary to ensure their identity, purity, and to detect any changes that could impact the quality of the final product. These rigorous requirements can be a daunting task for developers who may lack the expertise, resources, or capacity.

By leveraging a partner who will generate, monitor, and perform release and characterization testing of an MCB, developers can be confident that the cells remain stable and consistent over time, which is essential for ensuring the quality and safety of the final product.