Remicade/ Remsima/ Inflectra (Infliximab)

Biosimilar Characterization Considerations

Structural Characterization

Physicochemical Characterization

Functional Testing by Custom Biologics

  • Cell Proliferation Assays
  • TNFα Neutralization Assay
  • Antibody-dependent cell cytotoxicity (ADCC) Reporter Bioassay
  • Complement-dependent Cytotoxicity (CDC) Assays
  • Binding Assays– TNFα, Fc-Receptors, C1q, FcRn
    • ELISA
    • MSD
    • BLI

Product Specific Technical Considerations

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