Master Cell Bank

Master Cell Bank. The fully characterized cells expanded and vialed into a series of aliquots, and maintained in a state of frozen suspension.

Master Cell Bank. Viable E. coli containing Parent Plasmid, transformed directly from CUSTOMER supplied stock under GMP conditions, diluted in glycerol and stored in sealed vials at less than minus sixty degrees Celsius.

Master Cell Bank. Shall mean a single pool of E. coli cells or CHO cells expressing the TriKE Product that has been derived from the RCB using a single E. coli cell clone or CHO cell clone expressing the TriKE Product. The MCB will be prepared under CGMP conditions in accordance with the applicable Manufacturing Process, and subsequently dispensed into multiple containers, and stored under defined conditions. The MCB is used to derive all working cell banks used to manufacture an Engineering Batch or CGMP Batch.