Purpose of stability testing is to understand how a biopharmaceutical product changes over a defined period of time under certain conditions (temperature, air humidity, light). The shelf-life and the recommended storage conditions for a biopharmaceutical product among other information can be derived from the results.
JAFRAL can provide template of stability program, but then every stability study is treated as a customised order. Depending upon the product and the project phase, you will require a coordinated range of services over a wide range of climatic conditions as well as physical, chemical and microbiological tests.
JAFRAL offers long-term and short-term stability testing for biopharmaceutical products.
Stability Testing program follows the ICH Final Guideline on Stability Testing of Biotechnological/Biological Products and FDA Guidance for Industry Q1A (R2) Stability Testing of New Drug Substances and Products.
Testing can be performed on:
- Research/ Process development material
- Cell/Virus banks,
- Drug substances
- Drug products/Placebo
- Various intermediates
Example of temperature conditions:
- Accelerated conditions (e.g. 40±5°C)
Control of relative humidity can be included if needed.