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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, and drug regulatory authorities around the world maintain strict limits on its residual level. 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 "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". Pharmacopoeias in various countries have successively provided several classic methods for detecting residual host cell DNA, and the real time quantitative polymerase chain reaction (qPCR) method is the current optimal choice.

Series of residual DNA fragment analysis kits independently developd by Junyan Bioscitech 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:

  • Low concentration repeatability CV value < 20%

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

  • Strong specificity:

    Unaffected by exogenous DNA from CHO and E. coli.

  • Fast and convenient:

    qPCR results avaliable within one hour.

Performance Indicators

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

  • Detection principle: Fluorescent probe-based 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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