Poster: Direct Quantification of Residual Host Cell DNA
Presenter: Nancy Ngo, Bio-Rad Laboratories
About: Many therapeutic proteins and vaccines are manufactured using bacterial and mammalian host cells. Manufacturing processes are prone to leaving biological impurities from these cells, such as host cell DNA (HCD). The presence of HCD in drug substances poses safety concerns and must be removed to ensure product quality and safety. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO), have provided guidelines defining acceptable levels of HCD allowed in final drug products; the upper limit is 100 pg/dose and 10 ng/dose as stated by the FDA and WHO, respectively. Therefore, the method to quantify residual HCD and monitor DNA clearance should be highly sensitive to meet these regulatory requirements. Here, we introduce a highly precise and sensitive method for residual HCD quantification, without the need for DNA extraction, using droplet digital PCR (ddPCR). We created a panel of test matrices to simulate various process intermediates and analyzed these samples using ddPCR. Spiked-in DNA can be fully recovered even in complex matrices with high precision and femtogram-level sensitivity. The results from our study clearly show the effectiveness of ddPCR in detecting residual HCD by a direct method and without the need for DNA extraction.
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