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Large molecule therapeutics can be particularly sensitive to environmental factors and require advanced analytical capabilities integrated with compliant quality systems to evaluate the quality of the product under various conditions and timeframes.
Stability studies for large molecule products can involve a diverse range of analytical technologies all of which are available to GLP and cGMP standards in our laboratory.
Alternative analytical techniques may also be required to probe post translational modifications such as:
Storage Protocols
The basic stability study requirements are described in the ICH guidelines Q1A(R2) "Stability testing of new drug substances and products" and Q5C "Quality of biotechnological products - Stability testing of biotechnologicals / biological products". During early stage drug development, accelerated stability studies can provide shelf life data and information on the effect of short term exposure to environmental conditions typically performed over a 6 month timespan. Long term stability studies (12-months up to 5-years) allow evaluation of the quality of the drug both during and beyond its projected shelf-life.
Request more information to see how Intertek can help your organization with Stability Studies for Biopharmaceuticals.
