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HEK293 Residual DNA Fragment (qPCR) Detection Kit
Item number：FH20311D-4×100
Specs：4×100 R
Sell-by date：12 months
Storage conditions：-20℃
Technical support：19503412257
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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, and 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 tat "Control of residual DNA residue and fragment size is required. DNA residue should be kept below 10 ng per dose where possible, and residual DNA fragment size should be maintained under 200 bp." Pharmacopoeia of each country has also introduced several classic methods for host cell residual DNA detection, with real-time quantitative polymerase chain reaction (qPCR) currently being the optimal approach.


Several residual DNA fragment analysis kits independently developed by Junyan Bioscitech  can rapidly and specifically detect the size distribution of residual DNA fragment 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 the host residual DNA sample pretreatment kit of our company.


Advantages and Features


  • High Stability:

    Less affected by environmental factors, with stable performance within the shelf life.

  • High Precision:

    • Low concentration repeatability CV value < 20%;
    • Medium and high concentration repeatability CV value < 15%.

  • Strong Specificity:

    Unaffected by exogenous DNA from CHO or E. coli.

  • Rapid and Convenient:

      qPCR results available within 1 hour.


Performance Indicators


  • Linear Range of Standard Curve: 30 fg/μL – 300 pg/μL

  • Detection Principle: Fluorescent probe-based qPCR method

  • Limit of Quantitation (LOQ): 30 fg/μL

  • Applicable Instruments: Suitable for multiple domestic and imported quantitative PCR instruments

  • Fluorescent Group: FAM

  • Shelf Life: 1 year at -20°C


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