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dc.contributor.authorSzajek, Anita Y.
dc.contributor.authorChess, Edward
dc.contributor.authorJohansen, Kristian
dc.contributor.authorGratzl, Gyongyi
dc.contributor.authorGray, Elaine
dc.contributor.authorKeire, David
dc.contributor.authorLinhardt, Robert J.
dc.contributor.authorLiu, Jian
dc.contributor.authorMorris, Tina
dc.contributor.authorMulloy, Barbara
dc.contributor.authorNasr, Moheb
dc.contributor.authorShriver, Zachary
dc.contributor.authorTorralba, Pearle
dc.contributor.authorViskov, Christian
dc.contributor.authorWilliams, Roger
dc.contributor.authorWoodcock, Janet
dc.contributor.authorWorkman, Wesley
dc.contributor.authorAl-Hakim, Ali
dc.date2016
dc.date.accessioned2022-06-23T04:20:07Z
dc.date.available2022-06-23T04:20:07Z
dc.date.issued2016-06-09
dc.identifier.citationThe US regulatory and pharmacopeia response to the global heparin contamination crisis, A. Y. Szajek, E. Chess, K. Johansen, G. Gratzl, E. Gray, D. Keire, R. J. Linhardt, J. Liu, T. Morris, B. Mulloy, M. Nasr, Z. Shriver, P. Torralba, C. Viskov, R. Williams, J. Woodcock, W. Workman, A. Al-Hakim, Nature Biotechnology, 34, 625–630, 2016.
dc.identifier.issn15461696
dc.identifier.issn10870156
dc.identifier.urihttps://hdl.handle.net/20.500.13015/5347
dc.identifier.urihttps://doi.org/10.1038/nbt.3606
dc.descriptionNature Biotechnology, 34, 625–630
dc.descriptionNote : if this item contains full text it may be a preprint, author manuscript, or a Gold OA copy that permits redistribution with a license such as CC BY. The final version is available through the publisher’s platform.
dc.description.abstractThe contamination of the widely used lifesaving anticoagulant drug heparin in 2007 has drawn renewed attention to the challenges that are associated with the characterization, quality control and standardization of complex biological medicines from natural sources. Heparin is a linear, highly sulfated polysaccharide consisting of alternating glucosamine and uronic acid monosaccharide residues. Heparin has been used successfully as an injectable antithrombotic medicine since the 1930s, and its isolation from animal sources (primarily porcine intestine) as well as its manufacturing processes have not changed substantially since its introduction. The 2007 heparin contamination crisis resulted in several deaths in the United States and hundreds of adverse reactions worldwide, revealing the vulnerability of a complex global supply chain to sophisticated adulteration. This Perspective discusses how the US Food and Drug Administration (FDA), the United States Pharmacopeial Convention (USP) and international stakeholders collaborated to redefine quality expectations for heparin, thus making an important natural product better controlled and less susceptible to economically motivated adulteration.
dc.description.sponsorshipU.S. Food and Drug Administration
dc.languageen_US
dc.language.isoENG
dc.publisherNature
dc.relation.ispartofThe Linhardt Research Labs Online Collection
dc.relation.ispartofRensselaer Polytechnic Institute, Troy, NY
dc.relation.ispartofNature Biotechnology
dc.relation.urihttps://harc.rpi.edu/
dc.subjectBiology
dc.subjectChemistry and chemical biology
dc.subjectChemical and biological engineering
dc.subjectBiomedical engineering
dc.titleThe US regulatory and pharmacopeia response to the global heparin contamination crisis
dc.typeArticle
dcterms.accessRightsA full text version is available in DSpace@RPI
dcterms.isPartOfJournal
dcterms.isVersionOfhttps://doi.org/10.1038/nbt.3606
dc.rights.holderIn Copyright : this Item is protected by copyright and/or related rights. You are free to use this Item in any way that is permitted by the copyright and related rights legislation that applies to your use. For other uses you need to obtain permission from the rights-holder(s). https://rightsstatements.org/page/InC/1.0/
dc.creator.identifierhttps://orcid.org/0000-0003-2219-5833
dc.relation.departmentThe Linhardt Research Labs.
dc.relation.departmentThe Shirley Ann Jackson, Ph.D. Center for Biotechnology and Interdisciplinary Studies (CBIS)
rpi.description.pages625-630
rpi.description.volume34


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