Paragon Bioservices 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,
Vapor phase liquid nitrogen (below -135°C)
- 2°C to 8°C