Currently, we are planning on condcut long term stabiltiy for a drug storage under -40 degree C. we are planning on using -40C freezer from thermo Fisher to do the stability study. The IQOQ standard of this kind of freezer is +and- 3 degree C. Is that acceptable?
Hi
Having studied stability and freezing for both cell therapy and viral products, I don't have a lot of experience on the pharma side. If it is a chemical entity, look for conformational changes from bond angle rearrangment on freeze and thaw. If a peptide chain product, look for changes in binding efficiency with a Ka assay compared to product at 2-4 C.
I am attaching a file on extrapolating stability from accelerated storage along a time-temp plot. This allows an approximation of expected stability at longer time points using lower temps.
My take-away on the regs is that you're Ok with up to 20% loss of potency in long-term storage, unless your product becomes toxic due to temp-induced changes.
Good Luck
Bruce
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