Method validation of Q-PCR detection of host residual DNA in antibody drug based on protein A magnetic beads

Publication date: Available online 18 September 2019Source: BiologicalsAuthor(s): Xiao-zhi Liu, Bin Zhang, Wei Zhao, Geng Li, Mei-ling Zhou, Jing-shuang Wei, Jing-hua Zhou, Jian Gao, Zhi-ming WangAbstractThe residual DNA derived from host cells in antibody drugs have potential safety risks. In this paper, the antibody in the test sample was removed by magnetic bead separation method, and the residual DNA were quantitatively determined by Q-PCR method. The residual DNA in the sample was analyzed according to the standard curve. We validated the species specificity, accuracy, precision, quantitative restrictions, reproducibility of this method. The results showed the linearrange was of 1 × 10−1～1 × 102 pg/μL and the curve linear was good, this method can specifically detect CHO cell DNA. Compared with the method of extracting residual DNA by magnetic beads, the method has the advantages of simplicity, rapidity and low cost, and can be used for quantitative determination of the residual host cell DNA in antibody drugs producted by CHO cells.

Source: Biologicals - September 19, 2019 Category: Biology Source Type: research