Charles River performs GMP-compliant 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 per 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.

Charles River Biopharmaceutical Services 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 see case study examples of stability testing programs, please view our webinar, "Supporting Stability Data through the BLA Process."*

*Available through The SourceSM

  • Over 15 years of experience in global regulatory environments
  • Consultation services available
  • Clearly documented customized study plan developed
  • Transparent and controlled records during and after study completion
  • Troubleshooting expertise
  • Complete range of ICH conditions
  • Sub-ambient conditions of -20 °C, -30 °C, -70 °C and -80 °C 
  • Continuously monitored through computerized systems with 24-hour contact to laboratory staff
  • All chambers routinely inspected and revalidated

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