Biotech Values

[DewDiligence]

Lovenox immunogenicity data—a gauge of manufacturing purity:

The FDA's argument -- which is nicely set forth in the first few pages of their surreply -- is that these two clauses give them the power --indeed obligation - to assure themselves of the drug's purity and that the immunogenicity testing was a means to that end.

This is exactly what I said more than a year ago in #msg-38682430:

Heparin per se has very low immunogenicity (it’s not a protein), and hence any immunogenicity that might be caused by a heparin-based drug would likely stem from impurities in the manufacturing process. ...data on immunogenicity that NVS/MNTA furnished to the FDA in Sep 2008 serves the purpose of verifying the product’s purity.

I reiterated these sentiments three weeks ago in #msg-52731692 and was surprised to find that some posters disagreed. Fortunately, the FDA and I appear to be on the same wavelength :- )