Multi-Angle Light Scattering (MALS) Detectors
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 Capsid Aggregation with the following details:
- Purpose / Rationale: To ensure safety by minimizing immunogenicity risk and to maintain potency.
- Typical Acceptance Criteria: SEC/AUC: Meets specification for % Aggregates (e.g., ≤ 5%). DLS: Z-average is within target range, low PDI, and no large aggregate peaks detected.