Stability Community

Hi All,

I'm looking to get feedback on industry practice for end of stability micro testing for DS and DP biologics during early clinical and pivotal. Are companies testing bioburden or sterility and endo on the final timepoint of stability protocols? Is this something agencies have asked for if left off?

I have been a part of programs for biologics that do run and file micro at the shelf life for early and late phases. Would be interested to know if this is not needed