Gel Documentation Systems
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 Vector Genome Integrity with the following details:
- Purpose / Rationale: Ensures the packaged DNA is full-length and able to express a functional therapeutic protein.
- Typical Acceptance Criteria: Meets specification for % Full-Length Intact Genomes. Truncated/rearranged genomes below predefined sponsor-justified limits.