Assay Development, Qualification & Validation

Bioassays are a critical component in the development and testing of biologics, determining the potency and understanding of the structure-function relationships of the protein. FUJIFILM Diosynth Biotechnologies' experience in biologics analytical development offers a strong platform for efficient and rapid method development, qualification and validation. Our robust systems ensure efficient development, with seamless and express transfer into GMP laboratories determining the potency and understanding the structure-function relationships of the protein.

Our formal procedures ensure that studies are ICH compliant ensuring analytical methods demonstrate robustness and competency. Our analytical team has experience in various validation strategies to perform assay validation providing assurance on the method performance.

  • Bioassay method development, qualification or ICH validaton
  • Cell based Bioassays (e.g. baculovirus titration, receptor activation, inhibition)
  • Biochemical and biological activity - Biacore, Octet, ELISA based bioactivity assays
  • Latest technology and instruments

Social Media

BannerImageBannerImageBannerImage