The Connecticut Separation Science Council is pleased to announce our first seminar of the year.
Please join us as we come together to share some food and hear Dr. John Jasper talk on the topic of biopharmaceutical compounds and stable isotopes
WHEN: Wednesday, February 17th 5:00 – 8:00 pm Dinner will be served from 5:30 – 6:30 pm Dr. Jasper will present after dinner
Register NOW: CSSC
Guests are invited to join the CSSC board of directors for their monthly meeting following the seminar
Dr. John P. Jasper
Chief Executive Officer of Nature’s Fingerprint® /
A Division of Molecular Isotope Technologies LLC
(of Niantic, Connecticut).
• The focus of Nature’s Fingerprint® is on authentication of
both pharmaceutical products and processes
by their natural-abundance stable-isotopic compositions,
particularly Intellectual Property Protection.
• More recently, they have expanded into in-process monitoring.
• 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.
• ~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 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.
An Overview of Intellectual Property Protection of Biopharmaceutical Compounds
via Natural-Abundance Stable Isotopes.
Addendum: Molecular Isotope Engineering
J. P. JASPER, P. FARINA, A. PEARSON, P. S. MEZES, and A. D. SABATELLI
Molecular Isotope Technologies LLC, Canaan Partners,
Harvard University, Mezes Consulting, and Dilworth IP, LLC
The natural distribution of light stable isotopes in bio/pharmaceutical products and synthetic pathways permits the characterization of compound sources and differentiation of potentially-infringing synthetic pathways. After reviewing five cases of product characterization, we will examine three cases of process authentication: one of false advertising and two of process patent infringement. The cases of product characterization demonstrate the dynamic range of the light stable isotopes in differentiating sources of bio/pharmaceutical materials. Most notably among them is the preliminary characterization of the anticoagulant biologic drug heparin. From initial analysis of five stable-isotope ratios (13C, 15N, 18O, 34S, and D), Principle Component Analysis reveals that the carbon (13C) versus oxygen (18O) relationship is the most significant in differentiating porcine, bovine, and ovine sources of heparin. These early results may find useful application in the monitoring of the international heparin market. In addition, three cases of process authentication will be examined to demonstrate the utility of natural-abundance stable isotopes in intellectual property protection.
In addition, we will report on the status of our recent work in Molecular Isotopic Engineering (MIE) is the directed stable-isotopic synthesis of chemical products for reasons of product identification and of product security, and also for intellectual property considerations. We report here the successful directed synthesis of racemic naproxen from its immediate precursors. We find excellent correspondence between the observed and predicted stable-isotopic results (13C, 18O, and D). 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.