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Understanding Stability Testing of Biological Products
  • Understanding Stability Testing of Biological Products

    This eLearning module reviews the regulatory guidelines specific to biologics, and the requirement for extensive testing of biotechnology products.​



    • Stability studies and their importance​

    • 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

      Deterioration before the end of its shelf life can make a biologic drug 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. 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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