The US regulatory and pharmacopeia response to the global heparin contamination crisis.

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 vul

SUBMITTER: Szajek AY 

PROVIDER: S-EPMC6516469 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature