Plate Reader
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 Serotype Identity with the following details:
- Purpose / Rationale: Confirms the correct viral vector is being used, which dictates tissue tropism and immunogenicity.
- Typical Acceptance Criteria: ELISA: Confirms binding to serotype-specific antibody. LC-MS: Confirms sequence of serotype-defining variable regions in capsid proteins.
From: Typical mRNA (Drug Substance) Specifications
This instrument is used in the context of measuring the Quality Attribute Residual Protein (IVT enzymes) with the following details:
- Purpose / Rationale: Ensures clearance of IVT enzymes (RNA polymerase, nucleases, capping enzymes) and bacterial host cell proteins.
- Typical Acceptance Criteria: < 100 ng/mg RNA.