Cell Bank Production & Storage
For more than 20 years, Charles River has successfully produced more than 1,000 cell banks for clients, including ones used for the manufacture of commercially available therapeutics. Our cGMP-compliant cell bank production assures a uniform population of cells are preserved and a sufficient supply of material is readily available for the life of the product. In conjunction with our cell banking and vaccine production services, we offer more than 10 years of experience with long-term storage of clients' banks.
Mammalian, Insect, and Stem Cells
Our cell banking team is capable of producing up to a 1,000-vial cell bank in cGMP-compliant suites. To provide clients with the best timelines, we have multiple cell banking suites available for manufacture. Standard release criteria of viability and sterility are provided, and full characterization and biosafety capabilities are also available for further regulatory-based testing of the client's cell bank.
Microbial Cell Banking
Our microbial cell banking team has a wealth of experience in manufacturing E. coli, yeast, and other aerobic and anaerobic microbial cell banks to the highest standards. As with our mammalian cell banks, microbial cell banking services are conducted under appropriate, controlled conditions. We have dedicated, fully-equipped CGMP-compliant suites with the capability to produce up to an 800-vial cell bank.
Cell Banking Support
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.
After the seed stock arrives, our project management team will guide you through the manufacturing process, from pre-seed testing and generation of the manufacturing batch record through the manufacture, release, and characterization testing of the cell bank.
Storage, Retrieval, & Shipment of Cell Banks
Maintaining the security and integrity of our clients’ cell banks is a priority. A multilayered approach is taken to ensure the security and performance of the cell storage facility. These practices, coupled with appropriate custody documentation, ensure that your cell bank vials are maintained under controlled conditions.
Storage of Cell Banks
- Cell banks are stored at -70 °C or in vapor-phase liquid nitrogen in a controlled-access area.
- Cell banks are divided and stored in multiple, validated, liquid nitrogen dewars.
- Separate dewars are maintained for quarantined (untested) and released materials.
- Once in storage, vial locations are identified, and unique identification numbers for each bank are provided to enable complete confidentiality and expeditious vial retrieval.
Cell Bank Retrieval & Shipment
- Cell bank retrieval and shipment occurs only at the request of an authorized client representative.
- Vials of a cell bank are removed from storage and transferred to an appropriate shipping container with a recording device that documents the temperature for the duration of the shipment.
- All vapor-phase liquid nitrogen shipments are shipped in a qualified dewar.
Frequently Asked Questions (FAQs) for Cell Banking
Why is cell banking important?
Cell banking provides a characterized, common starting source for each manufactured lot of product, and assures that an adequate supply of equivalent cells exist for use during the entire lifespan of the product. We adhere to the ICH Q5 series (Parts A, B, and D) quality guidelines.
What makes a cell bank a master cell bank (MCB)?
A master cell bank is produced first, usually from an initial clone, and should be prepared from cells at a low passage level. The characterization testing for a MCB is extensive, including tests for identity, purity (including freedom from adventitious agents such as bacteria, fungi, mycoplasma, and viruses) and genetic stability (if applicable).
What makes a cell bank a working cell bank (WCB)?
A working cell bank is produced from one or more vials of the master cell bank. The vial(s) from the MCB is/are expanded by serial subculture, pooled, and then cryopreserved as the WCB. The characterization testing for a WCB is less extensive than the MCB and only requires confirmation of identity and testing to demonstrate purity (including freedom from adventitious agents such as bacteria, fungi, mycoplasma, and viruses).
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 identity 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.