Stability

Full service stability programs for BDS and DP

Manufacturing quality control labFUJIFILM Diosynth Biotechnologies offers a full suite of testing required to support the release of the drug substance, drug product, placebo and stability studies.The Quality Control Team works very 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.

As a global organization, we have full on-site Quality Control Laboratories in all of our facilities.

Quality Control is responsible for several key activities including:

  • scientists in a labRaw material and environmental testing
  • Microbiology testing
  • Stability testing
  • In-process control, bulk drug substance and final vialed

We offer cGMP long-term and accelerated studies for:

  • Intermediates
  • Drug Substance
  • Drug Product
  • Placebo

Our Full Service Stability Services offering includes:

  • Complete range of intermediate, long term and accelerated ICH stability conditions
  • Multiple frozen temperatures (-20°C, -30°C, -70°C)
  • Dedicated teams for protocol development and design of studies
  • Limited-access controlled facility and storage chambers
  • 24-hour computer-monitored facilities
  • Redundant back-up electrical power
  • Development and validation of “stability indicating methods“
  • Capabilities to perform photostability, transport, freeze/thaw, in-use stability
  • Dedicated sample logistics team for stability staging, pulls and sample shipment
  • State-of-the-art cGMP analytical instrumentation, testing provided by well trained, experienced analysts
  • Technical support provided by knowledgeable analytical development staff