Replies to post #62022 on Biotech Values

[Biowatch]

MNTA's share price climbed because they helped the FDA determine what the problem was with heparin.

Yes, it is important that the heparin supply is safe, but the FDA has limited resources to monitor everything manufactured overseas.

The FDA cannot possibly oversee all oversea manufacturing facilities, including those in China, where the government expressly disavows the need to monitor products produced for export.

MNTA should avoid acting as a surrogate regulatory entity overseeing product purity of biologics whose manufacture and true QA they have no control over, lest they set a large red bulls eye over their corporate logo with the phrase, "SUE ME' writ large.

[stockdak]

MNTA

True. Although I thought they added requirements for immunogenicity rather than altering existing guidance? I don't know but I see your point it seems that the FDA could easily add requirements for further analysis from TEVA et al.

I see from the Nat Biotech pub that NMR was the main tool for identifying the over sulfated chondroitin sulfate. Though not as sensitive as the MS analysis if there is a contaminant there at similar levels to the native components it will show up as an extra set of peaks. Also interesting that these authors conclude that the OSCS is not a natural contaminant.

Here is the kicker though:
"This study also provides a set of screening methods that could be used to monitor the heparin supply and ensure the absence of oversulfated chondroitin sulfate contamination. For example, using the structural information presented here, it is now possible to (i) design reference standards that ensure accuracy, quantification and specificity of analysis for a given analytical method and (ii) devise an experimental protocol to clearly define the nature and extent, if any, of contamination in a given lot of heparin. Finally, the ramifications of these findings extend beyond scientific considerations and include clinical and health policy issues."

They are supplying the method laid out in black and white. Teva can use it as well right?