Residual DNA Testing Across Biotherapeutics: dPCR Workflows And A CDMO Perspective

Residual host cell DNA remains a closely watched quality attribute across biologics, vaccines, and advanced therapies, yet traditional quantification methods can slow programs down with manual steps, standard curve dependence, and added variability. Digital PCR offers a more streamlined path, with sensitive, reproducible measurement across diverse expression systems including Vero, Sf9/Baculovirus, Pichia pastoris, mouse, HEK293, CHO, and E. coli. Real-world implementation insights from KBI Biopharma add a practical perspective for CHO- and E. coli-derived programs, with attention to sample preparation, data interpretation, and workflow integration. Extraction-free approaches also show how in-process monitoring and lot release testing can move faster without sacrificing confidence.

See how you can simplify residual DNA testing across development and manufacturing.