Stability Studies

Paragon Gene Therapy provides both long-term and short-term stability testing for biopharmaceuticals. Stability Testing follows the ICH Final Guideline on Stability Testing of Biotechnological/Biological Products (Hubbard, 1996) and FDA Guidance for Industry Q1A (R2) Stability Testing of New Drug Substances and Products. Testing can be performed on reference standards, cell banks, virus seed stocks, drug substance, and drug product (final container).

Testing includes appropriately qualified stability-indicating test methods for purity, identity, and potency as defined during development or provided by the client. Other tests included in these studies most often include appearance, pH, and sterility/bioburden (at least initially and at study conclusion). The goal of these studies is to demonstrate the extent to which product quality varies with time under different conditions such as temperatures and humidity. Storage conditions available for these stability studies include:

Vapor phase liquid nitrogen (below -135°C)

  • -80°C
  • -30°C
  • -20°C
  • 2°C to 8°C
  • 25°C
  • 30°C
  • 40°C