cGMP Stability Studies

Begin stability testing early with Covance to address this important aspect of biotherapeutic development. Subsets of characterization tests are employed by Covance to assess cGMP stability.

Gain peace of mind that Covance offers fully validated and inspected stability testing facilities, including specialist environmental conditions and walk-in chambers.

Study types include:

  • ICH and non-ICH conditions
  • Accelerated testing and degradation
  • Short and long-term testing
  • Stress testing
  • Orthogonal stability indicating techniques

Have confidence in the analytical data you receive from Covance. Know you are covered by Covance's standing operating procedures (SOPs) if an out of specification event takes place.

Covance stability testing is offered at the following temperatures:

  • -80°C
  • -20°C
  • +5°C (40% relative humidity)
  • +25°C (60% relative humidity)
  • +30°C (75% relative humidity)
Biomanufacturing Support
Click here to learn more about Covance biomanufacturing support services. 

Develop, characterize, test and validate with Covance, no matter what technique or molecule you're pursuing. Our experience covers a wide range of biomolecules, including:

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