Key Manufacturers: Agilent
Quadrupole Time-of-Flight (Q-TOF) Liquid Chromatography-Mass Spectrometry (LC-MS) systems
Quadrupole Time-of-Flight (Q-TOF) Liquid Chromatography-Mass Spectrometry (LC-MS) systems combine the separation power of LC with high-resolution, accurate-mass MS detection. These instruments are used for characterization, intact mass analysis, peptide mapping, oligonucleotide analysis, and impurity identification, providing precise molecular weight measurements and structural information.
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