In this episode we decided to use a new approach in regulatory affairs and tell people how to fail their BLA (Biologics License Application) and piss off their FDA reviewers at the same time. In order to do that, Arvilla Trag, who is a Chemistry, Manufacturing and Controls (CMC) industry expert helped by walking us through the FDA CMC Hell where we met all kind of people from pharma companies and heard all kind of interesting ideas on how not to complete the CMC section.

We would like to apologize to anyone who accidently learnt something from our entertaining discussion!

You can read the transcript of our discussion here: https://solutionsop.co.uk/2026/04/1 ...