Mycoplasma detection

Mycoplasma species are common contaminants in cell cultures, virus stocks, and other biological materials. Due to their small size (~0.15 μm) and resistance to antibiotics such as penicillin and streptomycin, contamination frequently remains undetected. Mycoplasma can affect cell growth, morphology, metabolism, protein synthesis, and replication, compromising experimental outcomes and product quality.

BaseClear offers a validated PCR-based Mycoplasma detection service to rapidly and reliably assess contamination in cell lines, virus preparations, and related biologics.

Validated PCR test

BaseClear uses an extensively validated Extraction and PCR kit, implemented within an in-house validated workflow aligned with European Pharmacopoeia 2.6.7 principles for rapid and reliable detection of Mycoplasma contamination in cell cultures, virus preparations, and other biological materials.
The assay targets conserved regions of the Mycoplasma 16S rRNA gene, offering broad species coverage (>100) with high analytical specificity (10 CFU/mL).

By combining a validated kit with BaseClear’s performance-verified implementation, the service delivers sensitive, traceable, and reproducible detection and is available under GMP or non-GMP formats to support both research and regulated applications.

You submit…

Cell culture supernatant

To maximize test sensitivity, cell lines should be cultured without antibiotics for 3 days, and the culture media should not be refreshed during this period. If this is not feasible for the customer, we must be informed which antibiotic is present in the culture so that matrix-interference testing can be performed. 

You receive…

  • A validation-compliant report detailing the testing methodology, controls used, acceptance criteria, and complete results, ensuring full transparency and traceability.
  • An expert interpretation of findings, including assessment and explanation of any observed cross-reactivity or interfering substances, along with guidance on potential impact and recommended next steps.
  • A Certificate of Analysis (CoA), documenting compliance with regulatory requirements and confirming that all testing was performed according to validated GMP procedures.

Optional: Mycoplasma identification

Positive Mycoplasma samples can be further characterised by identification using MicroSEQ®. MicroSEQ® is a revolutionary system for the identification of microbiological samples, based on PCR and sequencing of the 16S/28S rDNA genes. This system provides accurate and reproducible results without the need for time-consuming growth.

Read more about our bacterial identification service

Mycoplasma testing data 2025

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Testimonial IFF R&D

We outsource many molecular biological activities to BaseClear. BaseClear has very good molecular biological equipment and people with extensive knowledge and experience in this field. Even though we have similar capabilities within our own organisation, it makes more sense for us to outsource these activities and apply our focus elsewhere. Important advantage of BaseClear are the quality of their services and their reliability regarding delivery times. Molecular biological work is not always predictable but the staff at BaseClear works very hard to perform conform our wishes and requests on the projects that we outsource to them.