TrueMass CDMS
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 Empty/Full Ratio with the following details:
- Purpose / Rationale: A key purity and potency attribute, as only full capsids are therapeutically active.
- Typical Acceptance Criteria: The specification is product-specific and justified by clinical and manufacturing data. It is typically set as a minimum percentage of full capsids (e.g., NLT 25%) or a maximum percentage of empty capsids (e.g., NMT 75%).