Thermo Fisher Scientific: QuantStudio™ series
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 Residual Host Cell DNA (hcDNA) with the following details:
- Purpose / Rationale: To ensure safety by minimizing the risk of oncogenicity or an immune response
- Typical Acceptance Criteria: Meets guideline-aligned, product-specific limits (amount per dose and, where applicable, DNA size control). ≤ 10 ng/dose (per WHO guidelines); Fragment size meets WHO guideline of <200 bp.
From: Typical mRNA (Drug Substance) Specifications
This instrument is used in the context of measuring the Quality Attribute Identity with the following details:
- Purpose / Rationale: Confirms mRNA encodes the intended protein.
- Typical Acceptance Criteria: Matches reference sequence for defined regions; no unexpected variants above defined reporting threshold (e.g., ≥X% of reads) in coding sequence/critical elements.