The US regulatory and pharmacopeia response to the global heparin contamination crisis
Loading...
Authors
Szajek, Anita Y.
Chess, Edward
Johansen, Kristian
Gratzl, Gyongyi
Gray, Elaine
Keire, David
Linhardt, Robert J.
Liu, Jian
Morris, Tina
Mulloy, Barbara
Issue Date
2016-06-09
Type
Article
Language
ENG
Keywords
Biology , Chemistry and chemical biology , Chemical and biological engineering , Biomedical engineering
Alternative Title
Abstract
The 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.
Description
Nature Biotechnology, 34, 625–630
Note : 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.
Note : 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.
Full Citation
The 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.
Publisher
Nature
Terms of Use
Journal
Volume
Issue
PubMed ID
DOI
ISSN
15461696
10870156
10870156