Sponsored by Agilent

Main Speaker: 

John Jasper, Ph.D.

Chief Scientific Officer and Founder

Nature's Fingerprint® Authentication

Molecular Isotope TechnologiesSM, LLC

Evaluating Practical Uses of Molecular Isotopic Engineering (MIE):  Authenticity, Security, and Intellectual Property Considerations

Abstract:  

Molecular Isotopic Engineering (MIE) is the directed stable-isotopic synthesis of chemical products for reasons of product authentication and of product security, and also for intellectual property considerations. We report here the successful directed synthesis of naproxen from its immediate precursors.  We find excellent correspondence between the observed and predicted stable-isotopic results (d13C, d18O, and dD).  The observed carbon-isotopic results are readily explained by the laws of mass balance and isotope mass balance.  By contrast, the oxygen- and hydrogen isotopic results require an additional assessment of the effects of O and H exchange, presumably due interaction with reaction-solution water.

A previous, cooperative study with the US FDA-DPA showed that individual manufacturers of naproxen could readily be differentiated by their stable-isotopic provenance (d13C, d18O, and dD; Wokovich et al., 2005).  Results from two out of three of the naproxen samples produced for this study correspond well to the naproxen results observed in the cooperative study.  A third does not readily correspond to any of the samples observed in the cooperative study because no associated naproxen appears to have produced from such a starting material. The general correspondence of the present and previous naproxen data illustrates the plausibility of MIE.  We suggest that MIE can be readily employed in the bio/pharmaceutical industry without alteration of present manufacturing processes other than isotopically selecting and/or monitoring reactants and products.

Biography:

•    B.A., Geophysical Sciences and Biology, The University of Chicago.

•    Ph.D., 1988, in Marine Organic and Isotope Chemistry
Jointly granted by M.I.T. and Woods Hole Oceanographic Institution.  

•    Postdoctoral Fellow and  Scientist in Stable Isotope Chemistry, 
Indiana University’s Department of Chemistry, in Bloomington, Indiana.

With:

•    ~30 publications in organic and isotope  geochemistry and in bio/pharmaceutical chemistry; and,

•    20 years in the pharmaceutical industry as an analytical organic and isotope chemist, with:

o    Pfizer-Cultor,
o    Drumbeat Dimensions (a pharmaceutical advisory firm), and
o    Nature’s Fingerprint® / Molecular Isotope Technologies LLC.

Also serving as a pro bono geochemist with the Niantic River Watershed Committee

 

===================================================================================================================================