The creation of a regulatory-compliant cell bank is an essential element in the production of uniform biological products. Cell banking systems provide assurance that a uniform population of cells is preserved, that their integrity is maintained and that a sufficient supply of material is readily available for the life of the product. Of equal importance is the maintenance of these banks in a secure, controlled and monitored storage environment. The implementation of an appropriate tiered cell banking system and storage program will assist in a compliant, reliable and expeditious path to market.
The Biopharmaceutical Services (BPS) group at Charles River has more than 15 years of experience in manufacturing cell banks in compliance with current Good Manufacturing Practice (cGMP). We typically manufacture more than 200 research and cGMP cell banks annually, and our processes for controlling manufacture have been developed from this large base of experience to ensure a smooth and successful outcome for your manufacturing campaign. We incorporate validated assays that support the development of master cell banks (MCB), working cell banks (WCB), research cell banks (RCB) and cells at the limit of in vitro (CAL) for production in the following expression systems:
For more information, please contact us at askcharlesriver@crl.com or 1.877.CRIVER.1.
|
Cell banking, cell banks, current Good Manufacturing Practice, cGMP, master cell bank, MCB, working cell bank, WCB, research cell bank, RCB, cells at the limit of in vitro, CAL, mammalian, microbial, yeast, stem cell
GMP Cell Banking Services | Charles River
Cell banking systems help assure that a uniform population of cells is preserved, that their integrity is maintained and that a sufficient supply of material is readily available for the life of the product. We manufacture cGMP-compliant cell banks.