QIAGEN Bio-Expo Live November 2025: Data, Quality, & Analytics

Consistent product quality and regulatory compliance are paramount, yet challenging, in biotherapeutics development. Achieving this relies on accurate and reproducible measurement of Critical Quality Attributes (CQAs) to ensure product safety and efficacy.

Digital PCR (dPCR) offers a superior method for absolute quantification without the need for standard curves, significantly boosting accuracy and data confidence. Its partition-based workflow delivers higher sensitivity, reproducibility, and tolerance to inhibitors compared to traditional qPCR. These advantages are crucial for vital applications like residual DNA analysis, mycoplasma detection, genome integrity analysis, and viral vector quantification. Furthermore, systems with integrated, all-in-one designs and 21 CFR Part 11–compliant software streamline operations from early development through GMP manufacturing.

Learn how dPCR can accelerate the accurate assessment of safety, purity, and potency in biologics and cell and gene therapies. View the full presentation below.