Stability Testing

Charles River performs GMP-compliant stability studies for biopharmaceutical and pharmaceutical products as well as 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 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 20 years of stability testing and successful support of clients' product applications. Charles River 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 titled Supporting Stability Data through the BLA Process.

  • Over 20 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
  • Degradation product identification services
  • 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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Maintaining the Stability of Biologics

A number of factors can influence stability, especially with highly-complex biomolecules. Niall Dinwoodie spoke with BioPharm International about the challenges in maintaining a stable environment for biologics.

Release Testing

Release testing services for bulk drug substances and clinical and marketed products for the European Union (EU), United States (US) and other regulatory-distinct markets.