ArticleNature biotechnology2016
The US regulatory and pharmacopeia response to the global heparin contamination crisis.
Article in Nature biotechnology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
45 citing papers in PubMed, 103 citations in OpenAlex.
- The protamine-to-heparin ratio: concept and clinical application.Canadian journal of anaesthesia = Journal canadien d'anesthesie · 2026Article
- Heparin: Over 100 Years of Anticoagulation.Handbook of experimental pharmacology · 2026Review
- Unraveling the Potential of Small Molecule Heparin Glycomimetics in Neuroregenerative Therapeutics.Journal of the American Chemical Society · 2025Article
- The history of heparin.Anaesthesia and intensive care · 2025Article
- Influence of Anticoagulants and Heparin Contaminants on the Suitability of MMP-9 as a Blood-Derived Biomarker.International journal of molecular sciences · 2024Article
- Synthesis of bioengineered heparin chemically and biologically similar to porcine-derived products and convertible to low MW heparin.Proceedings of the National Academy of Sciences of the United States of America · 2024Article
- Control of tissue homeostasis by the extracellular matrix: Synthetic heparan sulfate as a promising therapeutic for periodontal health and bone regeneration.Periodontology 2000 · 2024Review
- Article
- Effectiveness and Safety of Enoxaparin Versus Unfractionated Heparin as Thromboprophylaxis in Hospitalized COVID-19 Patients: Real-World Evidence.The Annals of pharmacotherapy · 2023Article
- Recombinant mucin biotechnology and engineering.Advanced drug delivery reviews · 2023Review
- Not Just Anticoagulation-New and Old Applications of Heparin.Molecules (Basel, Switzerland) · 2022Review
- Commercial Low Molecular Weight Heparins - Patent Ecosystem and Technology Paradigm for Quality Characterization.Journal of pharmaceutical innovation · 2022Article
- Nuclear Magnetic Resonance Methods in Structural Characterization of Glycosaminoglycans.Methods in molecular biology (Clifton, N.J.) · 2022Article
- Heparin and Derivatives for Advanced Cell Therapies.International journal of molecular sciences · 2021Review
- High sensitivity analysis of nanogram quantities of glycosaminoglycans using ToF-SIMS.Communications chemistry · 2021Article
- Investigation of the biological functions of heparan sulfate using a chemoenzymatic synthetic approach.RSC chemical biology · 2021Review
- Enzymatic Synthesis of Glycans and Glycoconjugates.Advances in biochemical engineering/biotechnology · 2021Review
- Developments in Mass Spectrometry for Glycosaminoglycan Analysis: A Review.Molecular & cellular proteomics : MCP · 2021Review
- Quality Control of Heparin Injections: Comparison of Four Established Methods.Analytical sciences : the international journal of the Japan Society for Analytical Chemistry · 2020Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 15 institutions in 4 countries.
Funding
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.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.