Human Total RNA Residue Detection Kit (PCR-Fluorescence Probe Method)

The European Medicines Agency (EMA) guidance on the quality, non-clinical and clinical aspects of Gene Therapy drug productsIn the "Principles", it is proposed that the residual RNA of the host cell should be considered to determine the purity of the plasmid."Technical Guidelines for Pharmaceutical Research and Evaluation of Gene Therapy Products in Vivo (Trial)""In vitro Gene Modification systemThe "Technical Guidelines for Pharmaceutical Research and Evaluation (Trial)" points out that process-related impurities are mainly introduced by the production process.Common items such as host cell proteins, host cell DNA, host cell RNA, packaging plasmids, and viruses for packaging should be includedThe impurity removal performance of the production process and the residual level of impurities were studied to evaluate the safety of impurity residueWhen necessary, impurities with potential safety risks should be included in the product quality standards for control.

This kit is based on the fluorescence quantitative PCR method. Primer probes are designed for the conserved sequences of the Human genomePrepare ready-to-use Human RNA quantitative reference materials, integrate reverse transcription and fluorescence probe qPCR detection techniques, and establishA rapid detection and highly sensitive real-time fluorescence quantitative PCR kit has been developed for the quantitative detection of biological productsResidual Human total RNA in it.

This kit is used in conjunction with the nucleic acid extraction or purification kit and DNA removal kit of Baorui Biology. The fastest usage time is 2 hoursThe residual amount of Human RNA can be detected within about 10 hours.

This kit has undergone comprehensive methodological validation in accordance with relevant regulations, guidelines and other document requirements, and can provide performance validation reports.