Fast And Sensitive Mycoplasma Detection Workflow Using RT-dPCR With Same-Day Results

Mycoplasma contamination leads to potential risk in biopharmaceutical manufacturing, where even trace levels can compromise product safety and delay batch release. However, digital PCR (dPCR) offers a faster, more sensitive alternative to traditional culture-based detection methods. By targeting both rRNA and DNA, RT-dPCR significantly improves detection accuracy, especially for low-level contamination that might otherwise go unnoticed.

The QIAcuity Mycoplasma Quant Kit streamlines this process with same-day results, built-in controls to prevent false negatives, and coverage of 127 mycoplasma species.

When paired with automated sample prep, the workflow supports high-throughput testing with minimal hands-on time and strong reproducibility across complex sample types. Being fully compliant with European, US and Japanese pharmacopeia standards, this approach enables reliable risk management and accelerates the delivery of advanced therapeutics.

This assay is compatible with the QIAcuity Nanoplate dPCR system and validated on challenging sample matrices, such as CHO cell culture supernatants and drug product, supporting testing from development through GMP release. By providing a powerful solution for low-level contaminant detection, it meets the quality expectations of global regulators and biomanufacturers. This high-precision method is suitable for routine mycoplasma monitoring in CGT workflows and other complex biological products.

For teams navigating regulatory demands and tight production timelines, explore how this workflow offers a powerful edge.