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HEK293 Residual DNA Fragment (qPCR) Detection Kit
Product Introduction
Residual host cell DNA may carry tumor or virus-related genes, posing potential risks. Drug regulatory authorities worldwide strictly limit its residual amount. China's National Medical Products Administration (NMPA) stipulated in the Technical Guidelines for Pharmaceutical Research and Evaluation of In Vivo Gene Therapy Products (Trial) implemented in May 2022 that "both the residual DNA amount and fragment size should be controlled, with a recommendation to limit residual DNA to within 10 ng/dose and DNA fragment size to within 200 bp." Pharmacopoeias globally have also introduced several classic methods for host cell residual DNA detection, with real-time quantitative polymerase chain reaction (qPCR) currently being the optimal approach.
Junyan Biotech’s independently developed residual DNA fragment analysis kits rapidly and specifically detect the size distribution of DNA fragments from multiple host cells (Human, Hela, 293 series including HEK293, 293T, etc.). The fragment distribution intervals include: <100 bp, 100–200 bp, 200–500 bp, and >500 bp. This kit is used in conjunction with our company’s host residual DNA sample pretreatment kit.
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