Heparins Custom Development
BOC Sciences can provide synthesis and manufacturing services for heparin and heparinoid drugs. Heparin drugs have significant effects in the treatment of thrombotic diseases, and are the only effective specific drugs in hemodialysis treatment. Heparin drugs are in rigid demand in the market, and with the expansion of clinical indications, their scale in the drug market is still gradually expanding. In addition to providing the production of heparin generic drugs, we also have strong R&D and innovation capabilities, which can help you launch new heparin APIs, so that you can always maintain your core competitiveness in the market.
Heparin is a strongly charged polysaccharide anticoagulant, and its manufacturing method strongly relies on the unique molecular properties of heparin, including its acidity, high charge density, and stability. Heparin is not a single structure, but a mixture of closely related structures. Heparin is synthesized in a more complex manner than proteins and nucleic acids, and it is not synthesized in a template-directed manner, which results in a high degree of heterogeneity in its structural properties. Fig. 1 shows the common disaccharides in heparin. Heparin exhibits its anticoagulant activity by potentiating antithrombin (ATIII). ATIII is an anticoagulant factor. Heparin-enhanced ATIII can inhibit the action of procoagulant factor IIa (i.e., thrombin) and Xa by covalent binding, reducing coagulation. Specific pentasaccharide sequences in heparin are able to activate a conformational change in ATIII that increases ATIII's affinity for Xa by approximately 1000-fold, resulting in increased inhibition of factor Xa. Heparinoids refer to a class of acidic polysaccharides that are similar in chemical structure to heparin and have anticoagulant activity, most of which exist in the form of sodium.
Fig.1 Major disaccharide found in heparin: (-4)-α-l-IdoA2S-(1-4)-α-d-GlcNS6S-(1-).
Fig.2 (a) Schematic representation of an industrial heparin purification process; (b) General process conditions and reagents; (c) Removed impurities.
Our services include but are not limited to the following:
Utilize chemical and fusion protein technology, customize the preparation method of heparin, and efficiently produce high-purity heparins and heparinoids.
Process Exploration & Optimization
We were able to explore and optimize key production processes by means of single-factor experiments, multi-factor combination experiments, and response surface data analysis to obtain optimal heparin process parameters. And on this basis, it was confirmed by experiments that the optimized production process can produce heparin products with stable quality.
Quality Analysis & Control
Starting from the quality standard research method of heparin, we establish a modern instrumental analysis method for heparin quality control research based on key indicators such as heparin's molecular weight, amino sugar, sulfate and structure, so as to make the quality control of heparin more comprehensive and improve the quality safety reliability of heparin drugs.
If you are interested in our heparins custom development service, please contact us immediately.
- Janytzen V, et al. From Farm to Pharma: An Overview of Industrial Heparin Manufacturing Methods[J]. Molecules, 2017.
- Mulloy B, et al. Pharmacology of Heparin and Related Drugs[J]. Pharmacological reviews, 2015.