BioPharmaSpec provides a complete solution for the characterization of LMWHs, including Enoxaparin characterization, comparability and biosimilarity studies.

LMWH is a class of anticoagulant medications used in the prevention of blood clots and treatment of deep vein thrombosis, myocardial infarction and pulmonary embolism. A number of LMWH products are on the market, each similar in structure but created using different initial chemical procedures e.g. Enoxaparin is created using alkaline beta-eliminative cleavage of the benzyl ester of heparin.

Biosimilar Characterization Considerations

These analyses  are performed on samples “as received” and are also applicable to Antithrombin III high and low affinity binding fractions of LMWH, providing a more detailed structural assessment of these two sub-populations.

Product Specific Technical Considerations

The complexity of the saccharide mixtures within these products (e.g. Degree of Polymerization (DP) and levels of sulphation) means that high end analytics should be applied within characterization and comparability assessments. The methods above have been implemented and developed by BioPharmaSpec to provide a wide breadth of structural and physicochemical data to allow rigorous assessments of LWMH products to be made.