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BIOPHARMACEUTICAL SPECIFICATION-SETTING

This article was originally published in The Gold Sheet

Executive Summary

...policies are evolving as industry and regulators explore how to use an expanding knowledge base to create more manufacturing flexibility. A risk-based hierarchical paradigm providing for an expanded role for "limits" vs. "specifications" is emerging from this effort. At a recent biotech CMC strategy forum, FDA and industry participants discussed the challenges of deciding what to set specifications on and how to set them. Relevant issues addressed included assessing the clinical relevance of product variants, the impact of limited manufacturing experience, and stability-related considerations. [Included in the issue are presentations by biopharmaceutical regulators from FDA’s centers for drugs and biologics on current specification-setting concerns.]

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