Biotech Values

[aslan2772]

GTCB drug equivalence.

"The general philosophy will almost certainly be that a transgenically-produced protein is a different drug than the same protein produced in a bioreactor."

I wonder if that philosphy is deeply imbedded with the regulatory agencies? Transgenically-produced protein can be thought of as in situ cell culture. This is outside my area of knowledge so I'll ask: if one switches cell lines (which possibly come from different species) in a bioreactor, does the FDA or the EMEA require a new clinical trial to show drug equivalence? What is most important here, the cell line/tissue type, the species, or the host (organism vs. bioreactor).