Flow Cytometer
Associated Analytical Procedures
Context in Practice: Example Specifications
From: Typical AAV Drug Product Specifications
This instrument is used in the context of measuring the Quality Attribute Potency with the following details:
- Purpose / Rationale: MoA-relevant biological function.
- Typical Acceptance Criteria: Relative potency meets validated range vs. reference (commonly 80–125% during validation; sponsor-justified for release).