"Can we use a non-GMP (development) cell bank to do cell culture process characterization for late stage programs? The cell age, cell performance, and product qualities at production stage are comparable to WCB cells."I think scientifically the approach can be supported, particularly with summaries of what may/may not be same/different between the development (non-GMP) and product cell banks and risk assessments to review the significance and impact of those differences. The question is more on the regulatory aspect: would the FDA or other authorities have concerns about this approach? Any direct experiences?Thanks!
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