Getting to market first starts with cell banking as the foundation for your biologics production. Cell banks should be used when cell lines are used in the biologics production. Particularly in case that your protein of interest will follow clinical studies, regulatory agencies require cell bank manufacturers to guarantee continued stability and safety of cell lines producing biologics under cGMP.
Why is cell banking important?
Cell banking provides a characterized, common starting source for each batch and ensure that there is an adequate supply of equivalent cells for use throughout the entire lifespan of the product.
At 53Biologics, we adhere to the ICH Q5 series (Parts A, B, and D) quality guidelines.
Cell banking is applicable to microbial, insect, stem cells and mammalian cell lines. However, each host requires different cell banking generation and characterization. Fortunately, all of them can be cryopreserved and stored in a stable condition at ultra-low temperatures until required.
The standardized preparation of cell lines is important to ensure the quality and safety of biological product during commercial production. The first key step in this process is the establishment of a Master Cell Bank (MCB) and Working Cell Bank (WCB).
If MCB and WCB are prepared correctly and properly managed they can provide reproducible and dependable supplies of identical cultures over many decades .
Master Cell Bank (MCB)
An MCB is defined as an aliquot of a single pool of cells that generally has been prepared from the selected cell clone under defined conditions, dispensed into multiple containers, and stored under defined conditions. The MCB is used to derive all working cell banks (WCB). The testing performed on a new MCB (from a previous initial cell clone, MCB, or WCB) should be the same as for the MCB unless justified.
Working Cell Bank (WCB)
The WCB is prepared from aliquots of a homogeneous suspension of cells obtained from culturing the MCB under defined culture conditions.
The Master Cell Bank (MCB) is derived and expanded from one-parent cell culture The MCB is produced using standardized laboratory procedures and characterized depending on the strain to ensure proper identity and demonstrate the cell bank is free from accidental contamination. The Working Cell Bank (WCB) is prepared from one or more MCB vials and tested in similarly to the MCB before being used in production.
53Biologist offers cGMP-compliant MCB & WCB storage services to clients who wish to maintain backup copies of their valuable cell lines that will be used for the manufacture of therapeutics biologics.
What are the best practices prior to manufacturing a master cell bank/working cell bank?
Prior to establishing the master cell bank, a sponsor should ensure that adequate documentation is available to detail the origin, source, and history of the cell line. To determine how far in advance planning and production of the master cell bank/working cell bank should begin, product manufacturing target dates should be considered.
- Pre-testing prior to initiation of cell bank production
- Lead times with contract service providers
- The need for a pilot/engineering bank
- Availability of raw materials
- Total time needed for cell bank characterization and associated documentation
What testing is required for a master cell bank/working cell bank?
Both the MCB and WCB should be tested for identification and purity. The master cell bank should also be tested for genetic stability. Some human epithelial cell lines, and all lines used for live virus vaccine production, should be tested for tumorigenicity. Newer, state-of-the-art tools such as next generation sequencing (also known as deep sequencing or massively parallel sequencing) may provide additional data about the cell line or aide in investigations, but are currently not required.
The Best partner for Cell Bank Production & Storage
53Biologics has generated and characterized more than 100 cell banks for our clients (many more not requiring cGMP compliance) that will be used for the manufacture of therapeutics biologics. Even being microbial (E. coli, Pichia or even more rare platforms) or mammalian, our cell banking team is able to generate the required number of vials in our cGMP-compliant clean rooms.
Our solid Quality systems and standards assures that all the vials of each master cell bank are generated and preserved assuring the enough supply of this material for the life of the product. The standard release criteria of viability and sterility are provided with a full characterization services for further regulatory-based testing of our client’s cell bank.
We offer many support services to expedite the receipt of cell seed stocks and production of cell banks. It is our top priority to make sure clients are constantly informed throughout the manufacturing process.
Our team of experts is able to offer assistance with import permits and provide appropriate shipping vessels.
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By partnering with 53Biologics, experienced in upstream and downstream optimization bioprocesses clients can meet their manufacturing goals using the most cutting-edge techniques available.
At 53Biologics we know that securing the manufacturing process facilitates success through clinical development and commercialization of our customers’ products.