A Working Cell Bank (WCB) is a collection of cells derived from a Master Cell Bank (MCB) and used in the manufacturing process of biopharmaceutical products, such as vaccines, gene therapies, and other biological therapeutics. WCBs are created to provide a consistent and stable supply of cells for the production of a specific biopharmaceutical product without the need to access the MCB frequently, ensuring its long-term preservation.
The process of creating a WCB generally involves the following steps:
- Expansion of the MCB: Cells from the MCB are thawed and cultured under controlled conditions to increase their numbers.
- Cryopreservation: After a sufficient number of cells have been produced, they are cryopreserved, typically by mixing them with a cryoprotective agent and storing them in liquid nitrogen or ultra-low temperature freezers.
- Storage: The WCB is stored in multiple aliquots or vials to ensure a consistent supply of cells for the production process.
- Quality control and testing: Similar to the MCB, each WCB 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.
The establishment and use of WCBs offer several advantages in the biopharmaceutical manufacturing process:
- Preservation of the MCB: By using WCBs for routine production, the MCB remains untouched for longer periods, ensuring its preservation and reducing the risk of contamination or loss.
- Consistency and reproducibility: WCBs provide a consistent source of cells, maintaining the quality and characteristics of the biopharmaceutical product throughout the production process.
- Regulatory compliance: WCBs are established and maintained according to guidelines and requirements set forth by regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), ensuring the safety and efficacy of the derived biopharmaceutical products.
- Traceability: WCBs allow for better traceability in the manufacturing process, making it easier to identify and address any issues that may arise during production.
In summary, WCBs play a vital role in the biopharmaceutical manufacturing process, providing a consistent, stable, and traceable supply of cells for the production of various therapeutic products while preserving the integrity and safety of the MCB.