Heparin is a complex biological medicine first used in 1935. The complexity of heparin and low molecular weight heparin present analytical challenges and offers adulteration opportunities. Regulators and manufacturers continually strive for improvement of analytical methods to ensure the safety and efficacy of these well-established anticoagulants and antithrombotics. This proposed theme issue is aimed to cover topics that were presented at the 7th Workshop on the Characterization of Heparin Products, held in London, December 12-13, 2017. This series of heparin workshop started in 2007 and the main aim is to bring regulators, pharmacopoeias and heparin manufacturers together in an informal forum to discuss regulatory and quality attributes issues related to the production of heparin and heparin related products.
The main topics covered at the 7th Workshop included regulatory perspectives on proposed re-introduction of bovine heparin to the US market, Brazilian pharmacopoeial monographs for porcine and bovine heparin, quality attributes of current bovine heparin products (characterization by NMR, molecular weight profiles, anticoagulant activities and process related impurities), different sources of heparin (ovine and recombinant), biosimilar low molecular weight heparins and new indications for heparin and heparin related products.
In addition to welcoming contributions from the researchers involved with the 7th Workshop on the Characterization of Heparin Products, we would welcome any manuscripts which fit within the scope of this Research Topic.
Heparin is a complex biological medicine first used in 1935. The complexity of heparin and low molecular weight heparin present analytical challenges and offers adulteration opportunities. Regulators and manufacturers continually strive for improvement of analytical methods to ensure the safety and efficacy of these well-established anticoagulants and antithrombotics. This proposed theme issue is aimed to cover topics that were presented at the 7th Workshop on the Characterization of Heparin Products, held in London, December 12-13, 2017. This series of heparin workshop started in 2007 and the main aim is to bring regulators, pharmacopoeias and heparin manufacturers together in an informal forum to discuss regulatory and quality attributes issues related to the production of heparin and heparin related products.
The main topics covered at the 7th Workshop included regulatory perspectives on proposed re-introduction of bovine heparin to the US market, Brazilian pharmacopoeial monographs for porcine and bovine heparin, quality attributes of current bovine heparin products (characterization by NMR, molecular weight profiles, anticoagulant activities and process related impurities), different sources of heparin (ovine and recombinant), biosimilar low molecular weight heparins and new indications for heparin and heparin related products.
In addition to welcoming contributions from the researchers involved with the 7th Workshop on the Characterization of Heparin Products, we would welcome any manuscripts which fit within the scope of this Research Topic.
