Stability Chamber Conditions for Biologics

[sharonb]

#25019

What is/are the most common storage conditions for stability studies for biologics?

[Walter Routh]

#25021

I would say -80 +/- 10C would be quite common or in that neighborhood for the bulk/DS material. Hopefully the actually final product is a bit more user friendly and it only -20C or even refrigerated. Ultimately it all comes down to how long you need the shelf life to be. For example, if 6MO at -20 is sufficient for the final product, I’d recommend that vs. trying for 2 years at -80C, unless.

[John O’Neill]

#25025

Agreed that -80C has become quite common for long term biologic studies. Also agree that warmer (less cold) stations are needed to outline the limits of handling and clinical usage. Preliminary studies should point the Stabilitarian to the temperatures which will best serve to confirm these points.

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