Visiting Scholar: Else Holmfred (University of Copenhagen)

Stanford Faculty Advisor: Page Chamberlain (Earth & Planetary Sciences and Earth System Science)


Drug counterfeits

According to WHO, up to 10% of all drugs worldwide are counterfeits, a severe threat to human health that causes thousands of deaths every year and has an enormous influence on global economies. The number of drug counterfeits is increasing yearly. Non-visual drug counterfeits are difficult to identify due to the absence of methods. Distinct isotopic ratios and trace elemental patterns appear in drugs from synthesis of active pharmaceutical ingredient and excipients including the manufacturing process. The key innovation of this project builds on decades of knowledge from isotope biogeochemistry, where isotopes have long been used to determine geographical origin based on the isotopic signatures of water and rocks to identify biochemical origins of organic compounds. Else proposes to establish new experimental methods to spot non-visual drug counterfeits by combining the advanced experimental isotopic and trace elemental techniques from biogeochemistry science with industrial knowledge and practices surrounding drug manufacturing. Else's hypothesis is that differences in isotopic ratios of light elements (H, C, O, N) and trace elemental patterns can reveal and possibly identify the geographic origin of counterfeit. Her objective is to establish new experimental methods to identify drug counterfeits in solid drugs through changes in isotopic ratios and trace elements. Else aims to 1) Establish new pharmaceutical methods to determine and understand isotopic and trace elemental fingerprint of drugs, 2) Remodel and transfer the geological triple oxygen isotope analysis to a pharmaceutical method to determine how water remnants leave a distinct isotopic oxygen pattern in tablets and potentially reveal the geographical origin of counterfeit, 3) Investigate and compare production batch variations in isotopic and trace elemental fingerprint with drugs from other producers and documented counterfeits.