Biology Reference
In-Depth Information
Figure 1. Cell banking is a two-tiered system. GMP, good manufacturing processes; MCB, master cell
bank; WCB, working cell bank.
Safety assessment
Once cell banks are generated,they must be characterized before they can be
used to manufacture a drug for clinical use, as per FDA industry guidelines [1].
Characterization is critical to ensure that the correct protein is being produced
by the cells and that the cell line is not contaminated by adventitious agents.
