Mycoplasma testing for confident product release
Expert mycoplasma testing solutions
Rapid and compliant
In the development of biologics and advanced therapies, the presence of mycoplasma can bring production to a standstill and have a long-lasting impact. The resulting decontamination procedures are costly, and time-intensive. Therefore it’s essential to ensure that your product is free from mycoplasma, as these microorganisms can harm patients, causing illnesses such as bronchitis or pneumonia, and degrade product quality. When even the smallest contaminant can compromise both product integrity and compliance, you need a partner with the scientific expertise and regulatory precision to detect issues early — and keep them from occurring at all. That’s why the world’s leading pharma manufacturers turn to the Eurofins BioPharma Product Testing (BPT) network of laboratories.
We deliver robust, harmonised mycoplasma assays that support regulatory compliance with global standards. Our solutions are designed to support safe, contamination-free, and efficient production. We offer a full suite of traditional, semi-rapid, and rapid mycoplasma testing services to suit both early-stage development and time-critical releases. For short-shelf-life therapeutics, such as cell therapies or other ATMPs, a 28-day wait for test results is not practical — making our rapid mycoplasma methods essential.
Each method is expertly validated and performed by our highly trained analysts — who have over 20 years of experience — using state-of-the-art technology, giving you confidence in both accuracy and speed. The team conducts mycoplasma clearance studies, including consultation and study design.
With laboratories across the Eurofins BPT network operating under strict GMP and ISO standards, we ensure test results are regulatory-ready no matter where your product is headed. Our scientists don’t just run tests — they act as collaborative partners, providing tailored consultation to help you choose the right assay the first time. Because switching methods mid-development is not only costly — it’s a risk you can’t afford. We perform mycoplasmastasis testing to qualify each assay for each test article, and have a formalised analyst training programme, including required proficiency assessments using blind samples.
Mycoplasma Assays
Eurofins BPT comprehensive mycoplasma services:
- Testing of master, working and end-of-production cell banks
- Unprocessed bulk harvest
- Cell culture raw materials (e.g., serum, trypsin)
- Final product release
- ATMPS
Our services
- Traditional methods
- Semi-rapid method (Hybrid Mollicute Screening)
- Rapid methods (Nucleic Acid method BioFire® assay and Coloration method MycoSEQ™ assay
MycoSEQ™ assay
The MycoSEQ™ assay is the current industry standard for rapid detection of mycoplasma contaminations. It is a real-time qPCR assay that detects mycoplasma DNA using a magnetic bead extraction of DNA and Power SYBR® Green dye. This allows for results in 5 calendar days. Results within 3 calendar days are achievable with prioritisation to meet tighter timelines.
BioFire® assay
The BioFire® assay encompasses the nucleic acid extraction, PCR plating, and analysis within a single cartridge. This reduction in steps decreases the timing of the test from start to finish. This system also targets RNA, of which the half-life is much shorter than that of DNA. By targeting RNA, there is a higher probability that any mycoplasma detected is viable, reducing the possibility of false positive results. With the BioFire system, mycoplasma results may be obtained within 3 calendar days. For some extremely tight timelines, 24-hour results can be achieved.
Both MycoSEQ and BioFire assays meet Ph. Eur. 2.6.7 guidelines, as well those set by USP and JP general chapters. Both methods have in silico validations of over 100 mollicute species performed by the vendor. Both method validations performed by the vendors have been confirmed with live-spike recovery studies performed at Eurofins BPT. With the advent of autologous cellular therapies, testing time is valuable, and these assays reduce that testing time to the minimum that is achievable with current technology.
Facilities & instrumentation
- Limited-access laboratories are pressure-controlled, HEPA-filtered and operate on independent air handling systems to prevent cross-contamination.
- Separate areas for testing of client test articles and handling of positive control strains, including a unidirectional workflow ensures handling of test articles prior to manipulating positive controls on each working day.
- Validated cleaning disinfection and environmental monitoring programmes.
- Access to our proprietary LabAccess.com system, with 24/7 easy access to study information, final reports and actual raw study data.