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Product Introduction
Like retroviral vectors, RCL can integrate into the cellular genome, which may activate proto-oncogenes, disrupt tumor suppressor genes or increase the expression of cell growth-promoting factors, thereby posing a risk of secondary tumors induced by integration. The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) newly issued the Technical Guidelines for Pharmaceutical Research and Evaluation of In Vivo Gene Therapy Products (Trial) and Technical Guidelines for Pharmaceutical Research and Evaluation of In Vitro Gene-Modified Systems (Trial) in May 2022, both of which mention that RCL detection, as a safety test, is crucial in the research and development as well as production of cell-based drugs.
Independently developed by Junyan Bioscitech, the RCL Gene Copy Number (qPCR) Detection Kit is designed for the viral envelope protein VSV-G gene. It features strong specificity and high sensitivity, enabling rapid and specific quantitative detection of RCL in lentiviral vector-related cellular products. This kit can be used in conjunction with Junyan Bioscitech's "Host Cell Residual DNA Sample Preparation Kit (Magnetic Bead)" and automatic nucleic acid purification instrument.
Performance Parameters
Linear range: 1×10⁶ copies/μL - 1×10¹ copies/μL, covering 6 concentrations
Linear correlation coefficient: R² ≥ 0.980
Amplification efficiency: 90% ≤ Eff (%) ≤ 110%
CV of the detection value for each concentration < 15%
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