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Plasmid DNA Residue (qPCR) Detection Kit
Product Introduction
Viral packaging systems are used to prepare viral particles. To enhance viral safety, the essential component sequences required for viral preparation are split into different plasmids, which remain in the product as residual exogenous DNA.
In May 2022, the Center for Drug Evaluation (CDE) issued the Guiding Principles for Pharmaceutical Research and Evaluation of In Vivo Gene Therapy Products, which clearly states that for viral vectors (such as AAV) that tend to package non-vector DNA into viral particles, the potential risk of packaging related exogenous DNA into viral particles should be considered when selecting packaging plasmids.
Junyan Bioscitech's independently developed Plasmid DNA Residue (qPCR) Detection Kit enables quantitative detection of various residual plasmid DNA in samples (e.g., lentiviruses, adenoviruses) through analyzing the common DNA sequences of plasmids used in the market. This kit features high specificity, high sensitivity and reliable performance. When used in conjunction with Junyan Bioscitech's Host Cell Residual DNA Sample Pretreatment Kit, it can accurately quantify trace amounts of residual plasmid DNA in samples.
Advantages and Features
High precision: CV of repeatability at low concentrations < 20%; CV of repeatability at medium and high concentrations < 15%
Rapid and efficient: Fast detection with results available within one hour
High sensitivity: Limit of quantitation is 5 copies/μL
Performance Specifications
Standard Curve Linearity Range: 1×10⁶ - 1×10¹ copies/μL
Reference Material: Linearised DNA Quantification Reference Material
Limit of Quantification: 5 copies/μL
Detection Principle: Fluorescent Probe-based qPCR Method
Fluorescent Group: FAM
Compatible Instruments: Suitable for multiple domestic and imported quantitative PCR instruments
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