Low Molecular Weight Heparin (LMWH) Products

Biosimilar Characterization Considerations

  • Intact molecular weight analysis, using on-line LC/ES-MS in negative ion mode and MALDI-TOF MS.
  • Strong anion exchange chromatography (SAX), performed on material “as received” and also after gel permeation chromatographic separation into discrete saccharide populations.
  • Gel permeation chromatography (GPC) with UV detection at 234nm and Refractive Index (RI) detection.
  • Analysis of the products of individual Heparinase digests using SAX. Digestions are performed using Heparinases I, II and III in separate experiments.
  • Analysis of the 1,6-Anhydro containing components. Samples are digested with a mixture of Heparinases I, II and III and the products are analysed using SAX.
  • 1D and 2D NMR analysis is performed of the samples “as received” and using GPC sub-fractions.
  • Secondary and tertiary structure using Circular Dichroism (CD) in the far UV mode.
  • Scanning UV spectrophotometry.

Product Specific Technical Considerations

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