Biologics
Potency strategy as a lifecycle system
Linking mechanism of action, critical quality attributes, assays, acceptance criteria, and manufacturing evolution.
Potency is not a single assay selected near submission. It is a lifecycle strategy that should mature with product understanding and process development.
Begin with biological activity
Translate the proposed mechanism of action into measurable biological functions. Identify which functions are most relevant to product quality and clinical performance, and document the limits of current knowledge.
Build an assay matrix
Use complementary methods when one assay cannot adequately represent complex activity. Define the role of each assay, its development stage, reference materials, system suitability, and acceptance rationale.
Plan for evolution
As manufacturing changes, assess whether assay performance, reference standards, and acceptance criteria remain suitable for comparability and routine release.
Further regulatory context
Read medical device regulatory definitions and authoritative references. Explore the workflows eeRegOS supports.
Editorial note: This content is educational and does not constitute legal or regulatory advice. Product-specific decisions should be reviewed by qualified professionals using current authoritative sources.