Services

Support for Stability

AATL offers comprehensive services to support the stability testing of your products. Our stability program can assist you in determining the appropriate storage conditions and shelf life of your sensitive product. Our laboratories and storage facilities are fully compliant with current Good Manufacturing Practice requirements.

Features of our stability program include:

  • Analytical Method Development and Validation. Our experienced scientists develop stability-indicating methods specific to your product and conduct validation of method parameters, including accuracy, precision, linearity, recovery and ruggedness, following regulatory and ICH guidelines
  • Analytical Testing. A wide range of assays to characterize your biological product and assess degradation and impurities
  • Storage Facilities. Stability samples are stored in our secure stability chambers

Protocol Development and Study Management

Our stability staff provides comprehensive study management services, including:

  • Study design and development of protocols that ensure your studies are conducted in compliance with ICH guidelines
  • Client-dedicated stability project managers oversee all aspects of your study throughout its execution at our facility