Residual Host Cell DNA Quantitation

Ensuring the safety and effectiveness of biologics is of utmost importance, and one critical factor is detecting the presence of residual host cell DNA during the manufacturing process. Host cell DNA refers to the genetic material derived from cells like CHO or HEK293, which are used to produce biologics. Regulatory guidelines from organizations such as the World Health Organization (WHO), the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA) stress the significance of controlling and monitoring residual host cell DNA levels in the final drug product. It is imperative to demonstrate that any host cell impurities are effectively removed or reduced to levels below the thresholds set by regulatory agencies during the downstream process of biopharmaceutical development.

PCR-based detection has emerged as the preferred method for quantifying the amount of host cell DNA due to its speed, sensitivity, accuracy, and cost-efficiency. Quantitative PCR (qPCR) and digital PCR (dPCR) are both widely used techniques for quantifying host cell DNA. These methods offer reliable and robust results, aiding in the assessment and control of residual host cell DNA levels in biologics.