[Discussion] can we stop arguing about lyophilised until somebody posts a number
can we stop arguing about lyophilised until somebody posts a number, and I want the answer with the reasoning attached rather than just the conclusion. Gel packs are designed for a duty cycle. A liquid pack at the end of a longer-than-expected transit is a pack behaving as specified, not evidence of an excursion in…
Agreed. The dry powder is the robust state; it is the solution that needs the care.
Right, and asking what the stability statement was written against is one line of email that reframes everything.
Careful. "The cold chain failed" is a strong claim and the evidence you have is a warm box.
Yes — reconstitution date on the vial. It is the number you will want and cannot reconstruct.
Powder or already in solution?
a summer lane and a winter lane are different lanes
Correction: that stability figure covers the lyophilised powder, not the reconstituted solution. Different claim entirely.
lyophilised powder is far more forgiving than the panic threads suggest