Residual DNA testing across biotherapeutics: dPCR workflows and a CDMO perspective

Residual host cell DNA (residual DNA) is a critical quality attribute across biologics, vaccines and advanced therapy modalities, requiring sensitive and reproducible quantification to support process development, in-process control and lot release. However, traditional workflows can introduce variability and delay release timelines due to reliance on standard curves, multiple manual steps and method complexity.

In this webinar, we will outline digital PCR (dPCR) workflows and performance for residual DNA analysis across a range of expression systems, including Vero, Sf9/Baculovirus, Pichia pastoris, mouse, HEK293, CHO and E. coli. We will discuss how a standardized dPCR approach can simplify method deployment across diverse programs.

KBI Biopharma will share real-life perspectives on implementing dPCR-based residual DNA workflows for CHO- and E. coli-derived programs, including considerations for sample preparation and data interpretation. The session will also explore how extraction-free dPCR workflows can streamline in-process monitoring and lot release testing, enabling faster decision-making and improved manufacturing efficiency. The webinar will conclude with practical guidance on assay selection and integration of residual DNA testing into development and manufacturing workflows.

Learning objectives:
– Understand dPCR-based residual DNA workflows and performance across multiple expression systems
– Evaluate how dPCR can improve workflow efficiency and data quality, including accuracy, linearity, and reduced turnaround time
– Learn from a CDMO case study on implementing residual DNA testing, including comparison to qPCR and the impact of extraction-free workflows on in-process monitoring and lot release