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Human Total RNA Residue (qPCR) Detection Kit
Product Introduction
The European Medicines Agency (EMA) stated in the "Guideline on the Quality, Non-clinical and Clinical Aspects of Gene Therapy Medicinal Products" that residual host cell RNA should be considered to determine plasmid purity. The "Pharmacopoeia of the People's Republic of China (2020 Edition), Volume III" specifies in the General Principles for Human Gene Therapy Products that indicators for detecting the physical and biological quantities of gene therapy products should be established, which can be determined through tests such as total particle count, infectious titer or infectious particle count, genomic DNA/RNA or plasmid DNA concentration. In addition, the "Technical Guidelines for Pharmaceutical Research and Evaluation of In Vivo Gene Therapy Products (Trial)" issued by the Center for Drug Evaluation (CDE) of the National Medical Products Administration clearly points out that process-related impurities introduced by the production process, such as host cell RNA, should be included in the product quality standards for control.
This kit is used for rapid and accurate quantitative detection of residual host cell total RNA in intermediates, semi-finished products, and finished products of various biological products. Based on the qRT-PCR detection principle, it features rapid detection, strong specificity, and reliable performance. The linear range of the kit is 200 pg/μL - 0.002 pg/μL, with a minimum detection limit of 2 fg/μL.
Performance Parameters
Standard curve linear range: 2 fg/μL - 200 pg/μL
Fluorophore: FAM/CY5
Limit of quantitation: 2 fg/μL
Run time: 80 min
Accuracy: Measurement deviation < 5%
Compatible instruments: Suitable for multiple domestic and imported quantitative PCR instruments
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