Glatiramer Acetate

Biosimilar Characterization Considerations

  • Amino acid composition analysis

    To provide a comparability assessment of the levels of each of the four amino acids in different batches/products.

  • N-terminal sequence analysis

    To provide a comparative, quantitative assessment of the levels of the four amino acids across the first 15 N-terminal residues within the oligomers.

  • C-terminal sequence analysis

    To provide a comparative quantitative assessment of the uncapped carboxyl C-termini.

  • Peptide mapping

    To provide comparative peptide mass and fragment ion information using LC-MS (with MSe) in various forms and from various enzymatic digests.

  • Intact molecular weight distribution

    To provide a comparative assessment of the molecular weight distribution of the various batches/products

  • NMR analysis

    To provide a comparative primary, secondary and tertiary structure analysis and also assess the comparative levels of capped and uncapped C-termini

  • Circular Dichroism (CD) and FT-IR analysis

    To provide an orthogonal further assessment of secondary and tertiary structure

  • Size Exclusion Chromatography with UV and Multiangle Light Scattering (SEC-UV and SEC‑MALS)

  • Imaging Capillary IsoElectric Focusing (icIEF)

Product Specific Technical Considerations

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