Chemical and Analytical Strategies for Biosimilars

While small changes in these parameters can impact the various chemical permutations for a given biotherapeutic, innovators can, under certain circumstances, change the host cell, fermentation process, purification process, and even manufacturing site, but the product can be validated without undertaking a complete new product development review

 

  • Biochemical and Biosimilar Characterization
  • Biosimilars multimodal techniques
  • Biosimilars bioanalytical methods
  • Bioassay for comparability and potency testing
  • Biosimilars LC/MS analysis for discovery, preclinical and clinical programs
  • Biosimilars GMP protein analysis
  • Biosimilars electrophoresis

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