BioReliance CRO research professionals are experts at Master Cell Bank production for our clients in Biopharma. Our cGMP production facilities and extensive technical and regulatory expertise provide the support you need for efficient product development to achieve regulatory approval. Facilities for cGMP mammalian and insect master cell banking are located in Rockville, MD and Glasgow, UK.
A master cell bank is critical to therapeutic product development and supports not only clinical development and manufacturing but also the commercial supply phase for biologicals. From the master cell line, a working cell bank is produced to ensure high quality production and for scale up to manufacture.
Successful cell banks include:
- Maintenance of a single master cell line
- Working cell banks with low passage numbers
- Identity confirmation by DNA Fingerprinting
- Purity testing including Mycoplasma, virus, and fungi detection
- Stability testing for expression constructs and viral vectors
In short, we ensure your precious cell lines are maintained for optimal production.
To find specific master cell bank services, use the search tool at the right or click here.
Below you will find some answers to common questions about Master Cell Banks and Working Cell Banks.
Master Cell Bank Manufacturing Details
Biologicals such as monoclonal antibodies and recombinant proteins are produced in cultured cell lines from humans, lower mammals, insects, and bacteria. These therapeutic producing cells are typically created through a process that involves:
- Gene transfection or transformation
- Screening for expression
- Cell expansion and characterization
While in culture, these cells must be passaged regularly increasing the chance of genetic alteration, contamination, or loss of expression constructs as the cells divide. Thus, for optimal drug production, it is critical that cells are passaged as few times as possible and that the original high producing clone is not lost or altered.
A master cell bank is created from the original therapeutic-producing cell and cryopreserved in multiple vials to prevent genetic variation and potential contamination by eliminating the total number of times a cell line is passaged or handled during the manufacturing process.
To see BioReliance’s cell banking services, use the search tool at the right or click here.
Working Cell Bank Details
A working cell bank is usually required for the later stages therapeutic development and manufacturing. These cells are produced from a single vial of the master cell bank that have been grown for several passages and cryopreserved.
BioReliance offers a variety of working cell bank options including:
- Campaign and Non-campaign
- Mammalian Cells
- Insect Cells
- Animal Origin Free (AOF) Cell Banking Suites
We can also produce and maintain working cell banks to support cell-based assays or as substrates for other assays.
To find the working cell banking services you need, use the search tool at the right or click here.