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293T Residual DNA Fragment (qPCR) Detection Kit
Item number：FHT0311C-4×100
Specs：4×100 R
Sell-by date：12 months
Storage conditions：-20℃
Technical support：19503412257
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293T Residual DNA Fragment (qPCR) Detection Kit

Product Introduction

Residual host cell DNA may transmit tumor - or virus - related genes, presenting potential risks. Drug regulatory agencies around the world have strict limits on its residual quantity. In May 2022, China's National Medical Products Administration (NMPA) released the Technical Guidelines for Pharmaceutical Research and Evaluation of In - Vivo Gene Therapy Products (Trial), clearly stating that "both the amount of residual DNA and the size of residual DNA fragments should be controlled. It is recommended to keep the residual DNA within 10 ng/dose and the size of residual DNA fragments within 200 bp." Pharmacopoeias in various countries have successively provided several classic methods for detecting residual host cell DNA, and currently, the real - time quantitative polymerase chain reaction (qPCR) method is the optimal choice.


Junyan Biotech's independently developed series of residual DNA fragment analysis kits can quickly and specifically detect the size distribution of residual DNA fragments from various host cells, including Human, Hela, and 293 - series cells such as HEK293 and 293T. The fragment distribution ranges are: < 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.

Advantages and Features

  • High stability: Less affected by the environment, with stable performance throughout the shelf - life.

  • High precision: The coefficient of variation (CV) for low - concentration repeatability is < 20%, and for medium - and high - concentration repeatability is < 15%.

  • Strong specificity: Unaffected by exogenous DNA from CHO and E. coli.

  • Fast and convenient: qPCR results can be obtained within one hour.

Performance Indicators

  • Linear range of the standard curve: 30 fg/µL - 300 pg/µL

  • Detection principle: Fluorescent probe qPCR method

  • Limit of quantification: 30 fg/µL

  • Applicable instruments: Suitable for a variety of domestic and imported quantitative PCR instruments

  • Fluorescent group: FAM

  • Shelf - life: One year at - 20°C

  • Product documentation: Product instruction manual


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