WCB (Working Cell Bank) and MCB (Master Cell Bank) are critical components of the manufacturing process for biopharmaceuticals, particularly in the production of therapeutic proteins and monoclonal antibodies. They represent well-characterized, consistent, and stable sources of cells for large-scale production in a controlled environment.
Master Cell Bank (MCB): An MCB is a collection of frozen vials containing a uniform suspension of cells derived from a single, well-characterized cell clone or cell line. The MCB is established after thorough characterization and testing of the cell line for stability, identity, purity, and functionality. MCBs are stored at ultra-low temperatures, typically in liquid nitrogen, to maintain cell viability over long periods.
The MCB serves as the primary source of cells for the production process. Establishing a well-characterized MCB ensures that a consistent and uniform cell population is used throughout the manufacturing process, which in turn ensures the quality, safety, and efficacy of the final biopharmaceutical product.
Working Cell Bank (WCB): A WCB is derived from the MCB by expanding the cells from one or more vials of the MCB under controlled conditions. The WCB serves as an intermediate cell source for routine production, reducing the need for frequent access to the MCB. This minimizes the risk of contamination and depletion of the MCB. Like the MCB, the WCB is also stored as a collection of frozen vials at ultra-low temperatures to maintain cell viability.
Before using a WCB in the manufacturing process, it undergoes a series of tests and characterizations similar to those performed on the MCB, such as stability, identity, purity, and functionality assessments. This ensures that the WCB maintains the desired characteristics and quality attributes of the MCB.
In summary, the MCB and WCB are crucial elements in the manufacturing process of biopharmaceuticals, ensuring a consistent and well-characterized source of cells for production. The MCB serves as the primary cell source, while the WCB is an intermediate cell source derived from the MCB for routine production. Both banks undergo rigorous testing and characterization to ensure the quality, safety, and efficacy of the final biopharmaceutical product.