Master & Working Cell Banking
MassBiologics is available to assist in strategic discussions regarding Cell Banking. Given the establishment of a Master Cell Bank ("MCB") produced in accordance with regulatory standards (21 CFR 610) is a requirement for all recombinant therapeutics; the timing of creating the MCB and Working Cell Bank ("WCB") will need to be considered. MassBiologics is experienced in the required documentation, confirmation and testing of cell lines.
In a typical circumstance approximately 200 MCB vials are created, divided and stored frozen at our production facility and at an offsite location.
A WCB will be created from a single MCB vial. After a limited number of passages, approximately 200 WCB vials will be produced and stored for subsequent use in the production of your product.