Log in
RegisterStorage conditions of plasma samples [Bioanalytics]
Dear Erol,
I guess you mean the lower limit, giving a range of -25°C to -15°C ?
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.
❝ 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.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Storage conditions of plasma samples Erol 2019-04-09 11:51 [Bioanalytics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Storage conditions of plasma samplesOhlbe 2019-04-10 10:25
- OT: Free access to the AAPS J Helmut 2019-04-10 10:46
- OT: Free access to the AAPS J Ohlbe 2019-04-10 11:45
- OT: Free access to the AAPS J nobody 2019-04-10 12:26
- Forum internal: ★ Helmut 2019-04-10 15:26
- Forum internal: ★ nobody 2019-04-10 15:42
- Forum internal: ★ Helmut 2019-04-10 15:57
- Forum internal: ★ nobody 2019-04-10 16:10
- Forum internal: ★ Helmut 2019-04-10 16:17
- Forum internal: ★ nobody 2019-04-10 16:33
- Forum internal: ★ Helmut 2019-04-10 16:17
- Forum internal: ★ nobody 2019-04-10 16:10
- Forum internal: ★ Helmut 2019-04-10 15:57
- Unique statuses mittyri 2019-04-10 16:02
- Unique statuses Helmut 2019-04-10 16:16
- Unique statuses nobody 2019-04-12 10:43
- Unique statuses Helmut 2019-04-10 16:16
- Forum internal: ★ nobody 2019-04-10 15:42
- Forum internal: ★ Helmut 2019-04-10 15:26
- Storage conditions of plasma samples Erol 2019-04-10 20:29
- OT: Free access to the AAPS J Helmut 2019-04-10 10:46
- Storage conditions of plasma samplesOhlbe 2019-04-10 10:25
Ing. Helmut Schütz