SGS has entered into a partnership with Nature’s Fingerprint, a Connecticut-based division of Molecular Isotope Technologies LLC, specializing in product and process authentication via natural tracers, to mitigate identity theft of bio/pharmaceutical products and the patented synthetic pathways by which they are produced.
Counterfeiting of products and infringement of patented processes are multi-billion dollar problems for the bio/pharmaceutical industry and their global supply chain. This partnership will enable SGS to provide its clients with a unique additional analytical service that uses cutting edge technology to verify product authenticity, process authenticity and product/process infringement.
Nature’s Fingerprint’s technology relies on the precise determination of stable isotope ratios (naturally existing tracers) obtained by combustion and mass spectrometric analyses of either bulk phases or specific compounds. The expertise of Nature’s Fingerprint’s scientific team is in the innovative application of these methodologies to bio/pharmaceutical products and processes, ranging from process authentication to raw material provenance identification and manufacturing process discrimination.
“Through this partnership, SGS now has the capability to enhance its analytical consulting and analytical service offering, especially with regard to comparability or biosimilarity studies,” commented Mark Rogers, Global Technical Director, Life Sciences. “SGS’s unrivaled experience in this field will now extend to the selection and categorization of reference material lots and manufacturing process profiling.”
With 20 laboratories offering contract analytical and bioanalytical services, SGS leverages its wholly-owned global network, present in North America, Europe, and Asia, to deliver harmonized solutions to large pharmaceutical and biotechnology firms. In addition to testing services for the bio/pharmaceutical market, SGS also provides Phase I-IV clinical trial management, and services encompassing data management and statistics, PK/PD modeling and simulation, pharmacovigilance and regulatory consultancy.