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.
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