A Master Cell Bank (MCB) is a collection of cells that have been extensively characterized and tested for use in the production of biopharmaceutical products, such as vaccines, gene therapies, and other biological therapeutics. These cells are carefully preserved and stored in a frozen state, usually in liquid nitrogen or ultra-low temperature freezers, to maintain their viability, stability, and genetic integrity over time.
The establishment of a MCB is a crucial step in the manufacturing process of biopharmaceuticals, as it ensures a consistent and reliable source of cells for the production of a specific therapeutic product. The MCB serves as the starting material for the manufacturing process and enables the production of Working Cell Banks (WCBs), which are derived from the MCB and used in the actual production of the biopharmaceutical product.
Several factors are considered during the development and maintenance of a MCB:
- Cell line selection: The chosen cell line must be well-characterized and appropriate for the intended application. Commonly used cell lines include mammalian cells (e.g., Chinese Hamster Ovary (CHO) cells), insect cells, yeast, and bacteria (e.g., E. coli).
- Cell line authentication and characterization: It is essential to verify the identity, purity, and stability of the cell line. This may involve karyotyping, testing for mycoplasma contamination, viral testing, and evaluating the expression of the desired protein or gene.
- Documentation and record-keeping: Detailed records must be maintained for the origin, passage history, testing, and storage conditions of the MCB. This information is crucial for regulatory compliance and traceability.
- Storage and cryopreservation: MCBs are stored in multiple vials under cryogenic conditions, often in liquid nitrogen or ultra-low temperature freezers. This ensures the long-term viability and stability of the cells.
- Quality control and testing: Each MCB must undergo extensive quality control testing to ensure its suitability for use in the production of biopharmaceuticals. This includes sterility testing, genetic stability testing, and testing for potential contaminants.
Regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have specific guidelines and requirements for the establishment, characterization, and maintenance of MCBs to ensure the safety and efficacy of the biopharmaceutical products derived from them.