Biopharmaceutical Testing Services | Charles River

stability testing 

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 askcharlesriver@crl.com or 1.877.CRIVER.1.

Discover the full range of Charles River Products and Services
The Source

For more information, contact us at:

1.877.CRIVER.1 (1.877.274.8371)
askcharlesriver@crl.com

view all

News & Events

view all
mai 14 - New Models for Evaluating COPD or ...
mai 11 - Expert Safety Testing to Accelerat...
juin 17-juin 20 -  Noordwijk aan Zee, the Netherlands - 19th MDO Meeting / 12th Europea...
juin 02-juin 05 - Vancouver, British Columbia - CALAS
juin 05-juin 05 - King of Prussia, Pennsylvania - Assessment of Immunomodulation for Bi...
juin 05-juin 08 - Saint Germain sur l’Arbresle, France - Charles River LAL Seminar Seri...
view all
RMS Specialist Montreal, Canada

Charles River Laboratories, Inc.