Biosafety testing of CHO biologics
• Rapid targeted NAT - a fast, ICH Q2-validated alternative to traditional in-vitro assays, accelerating CHO-based biologics manufacturing • Covers 39 qPCR targets across 15+ high-risk viral families (Hsu et al., 2024) for comprehensive detection • Uses TaqMan® chemistry with degenerate primers/probes for broad and specific viral identification, contamination-free and highly sensitive
• Fully aligned with ICH Q5A(R2) guidelines; NGS options available for in-vivo replacement and cell bank testing • Risk-based panel design enabling faster, confident batch release and shorter time to patient
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