The Ronzoni Institute was involved in an international medical emergency due to serious side effects associated with contamination of clinical heparin (see below). Through Prof. R. Sasisekharan of Harvard-MIT, the Institute was asked to collaborate with USA health agencies in the identification of the cause of the adverse events and quickly succeeded in the identification of a major contaminant which was also identified as the cause of the serious side effects. As a follow up the Institute had to face many analytical requests from heparin producers and utilizers and its Board of Directors decided to establish a new Ronzoni analytical working unit. The unit includes two staff researchers who utilize the Institute instrument park, with emphasis on NMR, LC-MS and systems for molecular weight determination. The unit is going to be recognized by the Italian Ministry of Health.
Text from Nature Biotechnology - 2008 (see article 281, doi 10.1038/nbt1407)
“Recently, certain lots of heparin have been associated with an acute, rapid onset of serious side effects indicative of an allergic-type reaction. …..Because heparin is a drug commonly used in the clinic, occurrence of these adverse events resulted in a crisis in the United States. Germany and other nations in the European Union have observed similar phenomena, turning this health problem into an international issue4,5…. To understand the structure or structures of the contaminant(s) present within specific lots of heparin, we sought to identify these contaminants. This exercise required the use of multiple orthogonal techniques, including multidimensional NMR, to overcome the challenges inherent in the analysis of complex polysaccharides, including heparin, which in and of itself comprises a complex mixture of glycosaminoglycan chains. In doing so, we were able to determine definitively the structure of the contaminant, isolate it and confirm its structural identity by comparison to a chemically synthesized standard”