A cell banking system is in place to ensure the supply of equivalent, well-characterized cells able to produce a biologic product over the course of its clinical and commercial lifetime. From a risk mitigation perspective, the cell banking system allows for a comprehensive characterization of the cells and minimizes the likelihood of detecting biological contaminants when cell banks are being used in manufacturing. A Working Cell Bank (WCB), derived from a parental Master Cell Bank, is an essential component of the typical compliant mammalian cell banking system. WCB vials are used to initiate manufacturing lot processes. Following WCB vial thaw, cells are processed through the inoculum expansion steps prior to inoculating the seed and production bioreactors. Manufacturers are responsible for a thorough quality assessment of the WCB prior to release for use in commercial manufacturing operations. Accordingly, a number of tests have to be performed for the WCB qualification. The present case-study outlines the current strategy for quality assessment as part of a recently performed qualification of a mammalian WCB for a commercial biologic molecule. The cell bank is firstly subjected to and required to pass a set of biosafety and identity tests. Secondly, because a change in manufacturing process was implemented for this additional WCB, a set of genetic stability tests were required. Thirdly, an assessment of the performance of the WCB had to be completed using a qualified Scale-Down model of the production bioreactor. This assessment ensured that product titer and other performance and quality attributes were similar between the new and the original WCBs. Lastly, performance of the new WCB was confirmed to be equivalent to the original WCB at commercial scale and was deemed to be qualified for commercial use. The new WCB was therefore qualified for use in manufacturing of the commercial biologic molecule.

Case-Study of qualifying a mammalian working cell bank for use in manufacturing of a commercial biologic

253rd National Meeting (2017)

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