[Explainer] excursion tables, and why "it got warm" is not a data point
excursion tables, and why "it got warm" is not a data point. It comes up every few weeks and the answer has not changed. Kept a vial at room temperature for eleven days by accident. Tested it out of guilt. It was fine. Wrote the reconstitution date on the vial for the first time last year. Have never once since…
Once in solution, the relevant risks are hydrolysis, aggregation and, for some sequences, oxidation. Refrigeration slows all three; freezing a solution introduces a separate risk at the ice interface.
Once in solution, the relevant risks are hydrolysis, aggregation and, for some sequences, oxidation.
Disagreeing with this line only: freezing a reconstituted vial is not a safe default.
Disagreeing with this line only: freezing a reconstituted vial is not a safe default.
Adding the practical version: ask which lines are held regionally before you order in July.
Push back: you cannot infer degradation from a temperature excursion alone. That is what testing is for.
Retitled: the original asserted degradation the post does not evidence.
Lyophilisation removes the water that drives most degradation pathways. That is why the dry cake is comparatively robust and the reconstituted solution is not.