Support Every Step of the Way

We provide analytical services in addition to contract manufacturing for  biopharmaceutical, diagnostics & life sciences organizations.

Stay focused and leave the testing to us.

Stability
studies and response
Compliance
guidelines and monitoring
Capabilities
and validation

Stability studies

Stability studies require a dedicated effort across long time periods, often tying up resources for years. Argonaut gives you the expertise and capabilities you need.

We’ll deal with the headaches of managing chambers, storage conditions, and testing, allowing you to focus on pursuing pre-IND submission, clinical trials, or commercialization.

Compliance

Staying current on both FDA and ICH guidelines in changing regulatory environments is a challenge. Argonaut’s stability team can help keep you in compliance and leverage cGMP programs to support your effort in establishing expiry dating for your intermediates and finished products.

  • cGMP validated environments
  • Validated Building Management System
  • 24/7 monitoring
Capabilities

We can satisfy regulatory requirements utilizing real-time, accelerated and freeze- thaw studies. With Argonaut’s fully equipped lab, a diverse range of assessments and methodologies can be engaged- from core characteristics to purity, identity, and potency parameters.

  • Assay transfer, qualification, and validation
  • Stability protocol generation, storage and testing
  • Comprehensive summary reports
  • Preclinical through Commercial Stability
LIKE YOU, WE ARE MAKERS...
Let's discuss the right solution for your team!

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