Validation Challenges for Bioassays

Contact Name:
Adam Fleming
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Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.

Unlike analytical test methods for small molecules, bioassays have unique requirements due to the variable nature of some critical components. Although some variability may be inherent, careful attention to setting appropriate limits and to robust qualification of critical components enhances the likelihood of success during validation.

Regulatory agencies expect pharmaceutical companies and biopharmaceutical companies to use validated methods for late phase work. The methods are used to test large molecule drug substance or drug product for identity, purity, and potency. Poorly developed and inadequately validated methods often have high failure rates when in production. Data submitted from poorly developed/validated methods is subject to additional scrutiny due to the excessively high failure rate that lowers confidence in the data that is produced.

Cell-based methods may be difficult to validate due to a lack of extensive testing during the development phase. Method validation requires careful design of the method during development and seamless implementation to meet regulatory agency expectations for the quality of assay methods used in testing of biopharmaceutical or pharmaceutical compounds.

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