>MNTA – IMO the mass spectrometry and chromatography methods to perform this analysis are no secret. Rather having the expertise to perform this assay routinely and analyze the results in a facile manner is the competitive advantage.<
You’re correct that the standard tests are no big deal. What is a big deal, evidently, is MNTA’s software that takes the various assays as input and builds a model that shows which molecular structures are consistent with the observed assays and—more important—which molecules structures are inconsistent with them. When all but one of the plausible candidate structures have been found to be inconsistent with the assays, the one remaining candidate is crowned by default.
The above description is of course an oversimplification, but it illustrates the essence of the technique. MNTA’s proprietary software is the key to the whole process.
MNTA also has proprietary know-how in the use of restriction enzymes, which modify the molecular structure of the compound in question in a manner that generates the data points fed into the proprietary software.
In short, there’s a helluva lot more to this technology than mass spec and chromatography.
>Does this mean that TEVA and Amphastar cannot analyze their generics to the same level as MNTA?<
MNTA thinks the answer is yes, and so does Sandoz. We’ll soon see if the FDA agrees.
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”
