Digital PCR Applications For Cell And Gene Therapy: High-Quality Detection Of Mycoplasma Contamination

By Janina Bracker, Julius Albers, Andreas Hecker, Anida Mesihovic Karamitsos, and Francesca Di Pasquale, QIAGEN

Process development and manufacturing of advanced therapy medicinal products (ATMPs) is complex and tightly regulated, requiring rigorous quality control to ensure the final product is free from contamination. Among these, mycoplasma contamination remains one of the most serious risks, capable of silently compromising product integrity and patient safety. As a result, global pharmacopeias have established stringent guidelines for rapid, reliable mycoplasma detection throughout the production cycle.

To meet these evolving standards, QIAGEN has developed a validated one-step RT-dPCR workflow that detects both mycoplasma rRNA and DNA with high sensitivity, even in complex matrices like AAV extracts and cell cultures. The QIAcuity® Mycoplasma Quant Kit achieves detection as low as 5–10 CFU/mL across the ten species listed in major pharmacopeias. Paired with inactivated Mycoplasma Standard CFU Kits, this system enables fast, biosafe, and compliant testing without handling infectious material.

Download the full poster to see how this solution simplifies compliance, accelerates decision-making, and protects cell and gene therapy workflows.