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Plasmid Residual DNA(qPCR)Detection Kit (Kanamycin Resistance Gene)
Product Introduction
In May 2022, the Technical Guidelines for Pharmaceutical Research and Evaluation of In Vivo Gene Therapy Products issued by the Center for Drug Evaluation (CDE) clearly stated that viral vectors such as AAV, which easily package non-vector DNA into viral particles, should consider the potential risk of foreign DNA packaging into viral particles when selecting packaging plasmids. Regulatory authorities stipulate that the DNA content in the final products of cell expression should be as low as possible, and highly sensitive methods must be used for quantification. General Chapter 3407 of the Chinese Pharmacopoeia (2020 Edition, Volume III) specifies that the methods for detecting host cell DNA residue include DNA probe hybridization, fluorescent staining, and quantitative PCR (qPCR).
The kit has a linear range of 1×10⁶ copies/μL to 1×10¹ copies/μL and a sensitivity of up to 5 copies/μL, meeting customers’ requirements for residue detection sensitivity. It enables precise and rapid quantification of plasmid DNA residues.
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