Manufacturing Heparin with Equivalent Chemical Composition from Different Animal Sources

David Keire

doi:10.1055/s-0039-1685164

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2019; 119(05): 688
DOI: 10.1055/s-0039-1685164

Invited T&H Insights

Georg Thieme Verlag KG Stuttgart · New York

Manufacturing Heparin with Equivalent Chemical Composition from Different Animal Sources

David Keire

¹Division of Pharmaceutical Analysis, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, St. Louis, Missouri, United States

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Abstract

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References

References
1 Number of reported cases of bovine spongiform encephalopathy (BSE) in farmed cattle worldwide (excluding the United Kingdom). Available at: http://www.oie.int/?id=505 . Accessed March 15, 2019
2 Background materials for the November 15, 2016 meeting of the science board to the FDA. Available at: https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/ucm527761.htm . Accessed March 15, 2019
3 FDA encourages reintroduction of bovine-sourced heparin. Available at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm600976.htm . Accessed March 15, 2019
4 Tovar AMF, Vairo BC, Oliveira SMCG. , et al. Converting the distinct heparins sourced from bovine or porcine mucosa into a single anticoagulant drug. Thromb Haemost 2019; 119 (04) 618-632