Mycoplasma detection
Mycoplasmas are contaminants of biological products derived from cell lines in the biopharmaceutical industry. Mycoplasmas can appear in cell culture as a result of contamination of the source cell lines themselves (cell substrates) or from adventitious introduction of mycoplasmas during production. Multiple contamination risk guidelines and technical papers on mycoplasma safety for the manufacturing of biological products are available.
Digital PCR can be used to detect contamination in cell cultures and other cell culture-derived biologicals. For example, the QIAcuity Mycoplasma Quant Kit is an RT-dPCR kit that detects rRNA and DNA, allowing for high sensitivity of the method. An internal amplification control prevents false negatives due to PCR inhibitors, improper RNA extraction or improper RT reaction. The probe-based assay can quantify and detect 127 different mycoplasma species.
Benefits of using nanoplate dPCR for mycoplasma detection
- Compliant: NAT (Nucleic Acid Technique) workflow for mycoplasma testing that is compliant with the European, US and Japanese Pharmacopeia
- Fast: No time-consuming cultivation of mycoplasma necessary
- Sensitive: Detection of rRNA enables a higher sensitivity than using only DNA because of the multiple copies present in a single bacterial cell (detection of < 10 CFU/mL). The assay is still able to detect DNA if the RT-step is skipped, enabling a high degree of flexibility.
- Pre-validated: The workflow has been extensively tested as part of a comprehensive validation report that can reduce your own validation efforts
- Ten Mycoplasma Standard CFU Kits for in-house validation or as positive control without introducing vital mycoplasma