Hi Vibha,
I recently brought this topic up with my CMC colleagues at Boehringer, and it also came up during discussions at the BEBPA HCP conference in Slovenia. The general consensus at the conference seemed to be that micro-HCPs are assumed to carry a relatively low immunogenicity risk.
That said, the paper you shared makes it quite clear that these micro-HCPs aren’t effectively cleared during downstream processing. Internally, we plan to treat them with the same level of criticality as conventional HCPs. It would be really interesting to see published EpiMatrix data from EpiVax specifically on these micro-HCPs—there’s definitely a gap there.
All the best,
Elisa