Demonstration of the stability of an active pharmaceutical ingredient is an essential component in the development and commercialization of biopharmaceutical products.
Charles River Biopharmaceutical Services (BPS) performs stability studies for biopharmaceutical and pharmaceutical products and drug substances at all stages of the registration process. We have considerable experience designing and conducting testing programs to support early development, formal submission studies to the International Conference on Harmonisation (ICH) guidelines and commitment studies for the continued marketing of existing drug products. This experience has been gained through more than 15 years of stability testing for clients and successful support of their product applications.
Fully mapped and monitored storage facilities are available for the complete range of ICH conditions plus the sub-ambient conditions of -20°C, -30°C, -70°C and -80°C more suitable for biological products.
Studies are conducted according to current Good Manufacturing Practice (cGMP) guidelines. BPS has been approved as a named laboratory on multiple product licenses by the US Food and Drug Administration (FDA), US Department of Agriculture (USDA) and European regulatory authorities.
To check which of our BPS facilities offer stability testing services, click here. For additional information, please contact us at firstname.lastname@example.org or 1.877.CRIVER.1.
Visit our Regulatory Document Library to access regulatory documents on stability from the FDA, EMA, MHLW, WHO and more.