Storage conditions of plasma samples [Bioanalytics]

posted by Ohlbe – France, 2019-04-10 08:25 (796 d 18:55 ago) – Posting: # 20136
Views: 5,102

Dear Erol,

» What should be the freezer storage intervals for plasma to be stored at -20°C. Our freezer's range is between -15°C and -40°C. We have a question for this. Question is upper limit is high and it must be maximum -25°C.

I guess you mean the lower limit, giving a range of -25°C to -15°C ?

» Is anyone can give me information for the stability of plasma samples -40°C is wrong and why?

Generally speaking, if your analyte is stable at -20°C it will be also stable at -40°C. The EMA guideline allows a bracketing approach for small molecules (i.e. if you demonstrate stability at -70°C and -20°C it will cover all temperatures in between). The FDA 2018 guidance goes farther and states that stability at -20°C would cover colder temperatures. The draft M10 guideline allows extrapolation to lower temperatures only for small molecules but allows bracketing for large molecules. This still remains from the Crystal City 3 discussions and White Paper (hey, this one used to be free and now seems to be only accessible for a fee ?). I've heard since at a number of bioanalytical conferences that there is no published data to back up this distinction between small and large molecules. My understanding from discussions at the 13th WRIB last week is that industry will try and have it removed from the M10 final guidance.

Oh, by the way: I doubt your -20°C freezer would be able to reach -40°C anyway.


Complete thread:

 Admin contact
21,518 posts in 4,498 threads, 1,524 registered users;
online 22 (0 registered, 22 guests [including 6 identified bots]).
Forum time: Tuesday 03:21 UTC (Europe/Vienna)

I suppose it is tempting, if the only tool you have is a hammer,
to treat everything as if it were a nail.    Abraham Maslow

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz