Stability Studies

CuriRx provides GLP and GMP stability studies for small molecules, antibodies, gene therapeutics, peptides, proteins, vaccines, generics, and biosimilars. Our scientists will perform phase-appropriate qualification or validation for the methods required for regulatory submission. Product release testing as well as short- and long-term stability storage and testing are available.

CuriRx houses ICH Guideline Stability Chambers:

  • 25°C ± 2°C / 60% RH ± 5% RH
  • 40°C ± 2°C / 75 % RH ± 5% RH
  • 5°C ± 3°C
  • –20°C ± 5°C
  • -80°C ± 5°C

Photostability Testing

Photostability is used to stress a protein under extreme conditions. Photosensitive drug products in use or in situ primarily encounter visible and UVA light. Photostability testing is typically performed under controlled conditions, resulting in the precise analysis of the effects on your products. CuriRx uses a Caron Photostability 6510 chamber for these purposes. These stability studies usually require 2-4 weeks at 25°C in a stability chamber.