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Analytical Development

At FUJIFILM Diosynth Biotechnologies we utilize analytics for efficient, quality driven and phase-appropriate development of programs.  Our analytical teams specialize in the development of assays to support scale-up, effective process monitoring and cGMP production.   

Core services include:  

  • Method Transfer   
  • Method Development  
  • Method Qualification  
  • Method Validation  

At FUJIFILM Diosynth Biotechnologies our analytical development activities are driven by:  

  • Innovating  
  • Building quality into the product, maximizing the design space and minimizing risk in method performance  
  • Maintaining a line of sight to manufacture  
  • Reducing development costs and timelines  
  • Utilizing high-through-put robotic resources and leading edge technologies to future proof your analytical portfolio  
  • Generating the appropriate data to support the regulatory transition into commercialization

Analytical development

General Analytical Capabilities:  

  • H/UPLC with a variety of detection modalities  
  • SDS-PAGE and Western blotting  
  • CE-SDS and cIEF  
  • Protein content  
  • UV spectroscopy  
  • Bioassays and Immunoassays  
  • Mass Spectrometry   
  • Product Characterization   
  • Process Residuals   
  • Biophysical Characterization  
  • Compendial methods