Sciex Q-TOF LC-MS 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 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 Poly(A) tail length, distribution, and heterogeneity with the following details:
- Purpose / Rationale: Determines mRNA stability, intracellular half-life, and translational efficiency. Ensures process consistency and product quality.
- Typical Acceptance Criteria: • Mean tail length: Within defined range relative to reference standard (e.g., target ± 10 nt; or specified range such as 100–120 nt)• Distribution profile: Consistent with qualified reference standard• Short tails (<30 nt): <X% (limits established during development)• Tail heterogeneity: Within process control limits