ICH Q6B Guideline Defines Analytical Framework for Biopharmaceutical Quality and Safety

The International Council for Harmonisation (ICH) Q6B guideline outlines specific expectations and a structured framework for the analytical characterization of biopharmaceutical products. It provides detailed guidance on the testing and evaluation of biological substances to ensure their quality, safety, and efficacy.

The document focuses on the structural characterization of biopharmaceuticals, addressing critical aspects such as physicochemical properties, biological activity, immunochemical properties, purity levels, and impurities. These parameters are essential for establishing product consistency during development and manufacturing processes. The guideline serves as a reference point for regulatory submissions related to biopharmaceuticals, offering clarity on the types of tests required and the standards that must be met.

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Source: GO-AI-ne1

Date: June 6, 2025

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Author

Mark Chiang