How stable is your product? Can it remain intact and potent during storage? To ensure the safety and efficacy of the product, Envigo helps you to determine shelf life and temperature effects on your GMP grade material. If your product is in early development, Envigo can also help you evaluate the intrinsic stability, determine degradation pathways, elucidate the structures of the degradative products and establish which analytical techniques are stability-indicating.
Envigo can support any of the four types of stability study:
- Real time stability study
- Accelerated stability study
- Forced degradation stability study
- Photostability study
Regulatory guidance for stability studies is provided by the following:
- ICH Q1A(R2) Stability testing of new drug substances and products
- ICH Q1B Photostability testing of new drug substances and products
- ICH Q5C Stability of Biotechnology/Biological Products
Envigo is highly experienced in all forms of stability study, from formal GMP studies to R&D based forced degradation studies, and that expertise enables us to meet your unique study needs. Our experienced stability scientists can design flexible, phase specific protocols to suit the intended purpose for the data and ensure it is fit for purpose. Additionally, Envigo operates a GMP compliant stability facility, including stability chambers set at all the recommended ICH accelerated conditions and standalone units that can be set to new temperatures and humidity, as required. The stability facility is operated under the auspices of the GMP Quality Assurance Group.