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Understanding Stability Testing of Biological Products

This eLearning module reviews the regulatory guidelines specific to biologics. Biotechnological drugs need to be managed differently from chemical drugs as they are complex, more sensitive, and require extensive testing.

  • What are stability studies and why are they essential

  • How does a biologic drug differ from a chemical drug and guidelines specific to biologics.

  • Classification of stability studies based on purpose and stage of product lifecycle

  • Step-by-step procedure for initiating and executing a new stability study including protocol approvals, selection of batches, study design, and evaluation of external conditions.

  • Studies conducted during development to determine optimal formulation conditions, container closure selection, shelf life determination and in-use stability.

  • Studies conducted for market authorization application, using at-scale batches to support appropriate conditions for storage, transportation, and usage

Why it matters

A product that deteriorates before the end of its shelf life can be ineffective and cause side-effects. Stability studies provide evidence on how the quality of a drug substance or drug product varies with time under the influence of environmental factors such as temperature\, humidity\, and light. They help establish a re- test period for the drug substance or a shelf life for the drug product and recommended storage conditions. Importantly\, they ensure that the drug retains its medicinal properties and conform to its approved specifications at the time of consumption and throughout its shelf life.

Who is it for

Employees in quality control and quality assurance teams involved in planning\, reviewing\, approving\, and conducting stability studies should complete this module.

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