The short answer is "yes" provided that the development cell bank was the source for the GMP bank and is comparable in terms of performance. However, the devil is in details and you need to evaluate "comparability" carefully between the development bank and the GMP bank with respect to the characterization data you plan to use for, e.g., to support GMP bank for production, etc. Two ICH guidance documents are useful to look at, Q7 Table 1 and Q5D. The US FDA generally follows ICH guidance but EMA guidance is a bit more stringent than ICH in terms of the stage of GMP bank requirements. However, practically EMA is flexible too as long as the manufacturer can appropriately justify a less stringent practice.
Hope it helps.
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Jingdong Zhu
Independent Consultant
Basking Ridge NJ
USA
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Original Message:
Sent: 05-May-2020 13:20
From: Anonymous Member
Subject: Cell banks for cell culture process development
This message was posted by a user wishing to remain anonymous
Hello,
one of my technical development colleagues posed this question to me today:
"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!