Biosimilars Analytical Strategies

Analysis of Biosimilars and biologics forms to be one of the most important aspect towards the biologics and biosimilar development process. The development pathway of a biosimilar is unlike that of a novel biotherapeutic, requiring earlier extensive analytical characterization. Analysis of biosimilar and biologics takes the longest stretch towards establishing the product in comparison with the original product.

Any manufacturer seeking to develop and market a biopharmaceutical product requires comprehensive physicochemical structural characterization of the (glyco) protein. For biosimilar products, this task is magnified and forms the basis for further comparability. 

  • Biosimilar Bioanalytical methods
  • Biosimilar Formulation
  • Bioassay for comparability and potency testing
  • Biosimilar GMP protein analysis
  • Biosimilar LC/MS analysis for discovery, preclinical, and clinical programs
  • Biosimilar Electrophoresis
  • Biosimilar Multimodal techniques
  • Bioanalytical Challenges

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