cGMP Release and Stability Studies

FUJIFILM Diosynth Biotechnologies offers a full suite of testing required to support the release of the drug substance, drug product, placebo and stability studies. We offer technical and quality expertise, ensuring cGMP compliant testing is conducted with a comprehensive report, supporting you in navigating the regulatory path for your biopharmaceutical.

We offer cGMP long-term and accelerated studies for intermediates, drug substance, drug product and placebo. Our in-house dedicated stability group evaluates your product's stability and also the process and product consistency.

We have on-site back-up storage units and dedicated spare capacity with 24/7 monitoring and rapid response systems.

cGMP testing

  • Spectroscopy/Chromatographic - UV; Reverse Phase; Size Execution; Ion Exchange
  • Electrophoretic - PAGE; IEF; CE
  • Biophysical - Biacore; Octet; ELISA; Bioactivity assays; Cell Based assays
  • Biophysical characterisation - CD; DSC; Fluorescence; FT-IR; Micro Flow imaging

Stability Studies and Storage

  • +5°C storage
  • +25°C / 60% relative humidity
  • +40°C / 75% relative humidity
  • -70°C freezer
  • -20°C freezer
  • Additional cabinets available to meet custom needs

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