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Analytical development for viral vectors and recombinant vaccines

Our experience with a wide variety of biological products, from analytical method development through validation, across different global sites, has equipped us to handle unique and challenging program requirements.

We develop, qualify and validate appropriate analytical methods for in-process monitoring and release testing, consistent with current FDA/EMA guidelines.

Our analytical teams can provide you with a wide variety of analytical tools your program requires for critical in-process testing, monitoring of unit operations, and process recovery.

FUJIFILM Diosynth Biotechnologies’ Analytical Method Capabilities

  • Cell-based assays – TCID50, plaque assays, potency assays
  • PCR/qPCR/ddPCR
  • ELISA
  • UVA280/BCA protein determination
  • SDS-PAGE, Western blot
  • CE-SDS
  • SE-HPLC, IEX-HPLC, RP-HPLC
  • Host Cell Protein
  • DNA
  • Particle analysis
  • Differential Light Scattering