A biosimilar (biologics) is a biological medicinal product which is highly similar to and has no clinically meaningful differences from an existing approved reference (Innovator) product.

The development and validation of robust bioanalytical assays to accompany nonclinical and clinical studies is most critical requirement of any biosimilar drug development program. However, the detail description of how these assays should be developed, validated and implemented with respect to the intricacies of demonstrating biosimilarity is not clear.

Intox has extensive experience in method development, method transfer, and method validation of tailored bioassays according to GMP standards, and conducting routine potency assays using cell migration, ligand binding, ELISA, cell signalling, cell proliferation and inhibition of proliferation, binding assays or competitive assays approaches. Intox’s team is proficient in understanding and handling your requirement on case by case basis and has capability to support your biosimilar endeavour to conduct.

  • Protein physico-chemical properties (ICH Q6B)
  • Originator product characterization
  • Reference standard characterization
  • Testing to demonstrate biosimilarity
    • Bioassays
      • In vivo activity: measuring therapeutic effect in animals
      • In vitro activity: measuring therapeutic effect in cells: cell proliferation, inhibition of proliferation, cell senescence, measurable changes in cell size or content
      • Enzyme assays
    • In vivo pharmacokinetic
    • Toxicology with immunogenicity
    • Bioanalytical methods for clinical pharmacokinetics, immunogenicity and pharmacodynamics
  • Lot release testing
  • Stability testing