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.