Late last year the draft NHS guidance on the assessment of stability of mAbs and other biological products was adopted by NHS National QA, it now has its yellow cover. You can get a copy of the document at the link below.
CMU have since circulated it as a standard to which suppliers are required to meet.
We were pleased to have made our contribution to the drafts of this paper and in the comming weeks/months we will supply examples of good and bad practice in relation to the techniques required by this guidance.
A STANDARD PROTOCOL for DERIVING and ASSESSMENT of STABILITY Part 2 – Aseptic Preparations (Biopharmaceuticals)