Quality Control and Stability

FUJIFILM Diosynth Biotechnologies' cGMP Quality Control department provides support to the manufacturing process through in-process monitoring utilizing a variety of techniques.

Our QC group works closely with the Analytical Development Team to ensure a rapid and seamless transfer of analytical methods as programs progress from process development to cGMP manufacture.

We offer a wide range of in-house analytical services including:

  • Microbiology - bioburden, organism identification, Endotoxin, facility monitoring (air and water analysis)
  • Separation science - GC, HPLC, Gel Electrophoresis (SDS PAGE, Western Blot etc) CIEF
  • Spectroscopy - UV/Vis, fluorescence, IR, FTIR and NIR
  • Biochemical - ELISA, bioactivity assays

Stability

Our in-house dedicated Stability department evaluates your product’s stability and also the process and product consistency. We have the capacity to monitor stability of a product at a variety of temperature and humidity ranges dependent on your intended market.

We can offer Stability programs as a stand alone service.

Support & Downloads

Social Media

BannerImageBannerImageBannerImage