Roche: LightCycler
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 Residual Plasmid DNA with the following details:
- Purpose / Rationale: Ensures plasmid DNA template clearance to meet regulatory safety requirements.
- Typical Acceptance Criteria: • ≤10 ng DNA/mg RNA (typical)• Product-specific limit based on maximum dose and regulatory guidance