Advanced Therapy Medicinal Products are revolutionizing treatment for severe diseases, but ensuring their safety before administration remains complex. Traditional Mycoplasma testing methods can delay timelines by weeks. Additionally, high cell density and nucleic acid loads further complicate reliable detection in quality control (QC) workflows. There is a pressing need for faster, validated methods that meet regulatory demands without compromising accuracy.
Download this article to learn how one cell therapy manufacturer optimized PCR-based Mycoplasma testing for in-house use, thereby reducing their turnaround times while maintaining stringent QC standards.