Analysis of the preparation and characterization of cell banks used in the production of biotherapeutics must be evaluated according to regulatory document ICH Topic Q5D “Quality of Biotechnological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechonolgical/Biological Products.”
Three cell banks are generally examined:
- The Master Cell Bank (MCB)
- The Working Cell Bank (WCB)
- And the End-of-Production Cell Bank (EPCB) or cells at the age limit of in vitro culture.
The tests carried out depend on the origin of the cells in question. For example, to guarantee the origin of the cell lines, isoenzyme analysis is generally requested, but if the cell line is derived from a heterohybridoma (e.g. human/mouse), DNA fingerprinting is at times required.