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Heparin Contamination and Issues Related to Raw Materials and Controls

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The Science and Regulations of Naturally Derived Complex Drugs

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 32))

Abstract

Heparin is a century-old polypharmacological drug critical for the practice of modern medicine. In recent years, there have been a number of issues arising in the preparation of heparin from food animal tissues. The most severe problem was the adulteration of porcine intestinal heparin with a toxic semisynthetic look-alike polysaccharide, oversulfated chondroitin sulfate, which resulted in a number of patient deaths. Since this crisis, regulatory and analytical control of heparin has been markedly improved; new challenges in securing the heparin supply chain have prompted the reintroduction of heparins from new animal sources . In future, the introduction of bioengineered heparins might offer better approaches for securing this critical drug .

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Author information

Authors and Affiliations

  1. Department of Chemical Processing Engineering of Forest Products, Nanjing Forestry University, Nanjing, China

    Yuanyuan Zhu

  2. Center for Biotechnology and Interdisciplinary Studies, Rensselaer Polytechnic Institute, Troy, NY, 12180, USA

    Yuanyuan Zhu, Fuming Zhang & Robert J. Linhardt

Authors
  1. Yuanyuan Zhu
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  2. Fuming Zhang
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  3. Robert J. Linhardt
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Corresponding author

Correspondence to Robert J. Linhardt .

Editor information

Editors and Affiliations

  1. Department of Biological Engineering, Koch Institute of Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, MA, USA

    Ram Sasisekharan

  2. Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

    Sau L. Lee

  3. Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

    Amy Rosenberg

  4. Director Emeritus, National Center for Natural Products Research, School of Pharmacy, University of Mississippi, Oxford, MS, USA

    Larry A. Walker

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© 2019 American Association of Pharmaceutical Scientists

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Zhu, Y., Zhang, F., Linhardt, R.J. (2019). Heparin Contamination and Issues Related to Raw Materials and Controls. In: Sasisekharan, R., Lee, S., Rosenberg, A., Walker, L. (eds) The Science and Regulations of Naturally Derived Complex Drugs. AAPS Advances in the Pharmaceutical Sciences Series, vol 32. Springer, Cham. https://doi.org/10.1007/978-3-030-11751-1_11

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