Heparin sodium is an important anticoagulant with many indications, use in blood transfusions and dialysis procedures and the treatment of embolisms. In addition to its function as a drug product, the heparin sodium drug substance is the starting material for low-molecular-weight heparins used in the treatment of deep vein thrombosis, such as enoxaparin and dalteparin. The raw material used to make heparin sodium is most notably derived from porcine, making it susceptible to livestock-related supply issues and potential adulteration. USP has many tools available for the quality assessment of heparin sodium drug substance and low-molecular-weight heparins, including impurity methods, potency assays, and NMR methods for identification. USP is leveraging these tools in approaching standards for alternative sources of heparin, including bovine derived material. This webinar will describe some of these methods and how they can be applied to bovine heparin and future standards for heparin from alternative species.

This webinar is the sixth in the “What’s New in Biologics?” series that shares the knowledge and expertise from USP staff and global experts on topics that will shape the future of biologics.
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Subject area:
Biologics

Objectives (If applicable):
n/a

Target Audience (If applicable):
Manufacturers of Heparin products, Porcine and Bovine
Lab personnel in research and development, manufacturing and production of Heparin products
Regulatory professionals
Quality assurance and quality control specialists and auditors