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Stability Assessment

Stability assessment is a crucial component of quality control (QC) testing to support successful drug development.
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Our stability offerings

A range of stability studies are required and are set out in ICH Q1A and ICH Q1B regulations.

Labcorp offers both real-time and accelerated stability studies within ICH-compliant stability suites that offer recommended standard temperature and humidity-controlled conditions, including studies for all recognized climatic zones. Client-specific stability conditions can also be assessed. Our laboratories routinely conduct over 700 stability timepoints per year using more than 5,000 stability assays.

Resources

Article

Forced degradation of biopharmaceuticals: Protein stress testing

Info Sheet

Formulation development: The key to product stability

Article

20 critical questions: Helping you optimize reference standards for your biopharmaceutical across its development life cycle