cGMP Release & Stability Studies

We ensure that cGMP compliant testing is conducted with a comprehensive report, supporting you in navigating the regulatory path for your biologic and vaccine therapeutics.

cGMP Release and Stability StudiesWe offer cGMP long-term and accelerated studies for:

  • Intermediates
  • Drug Substance
  • Drug Product
  • Placebo

Our in-house dedicated stability group can help you design your stability program,  evaluates your product’s stability and also the process and product consistency.

We have on-site backup storage units and dedicated capacity with 24/7 monitoring and rapid response systems across all of our sites.

Stability Studies and Storage Capabilities include:

  • +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