Unexplained Cell Culture Results? Hidden Mycoplasma Contamination Could Be the Cause  

Mycoplasma contamination remains a persistent challenge in cell culture laboratories and the biopharmaceutical industry. It is estimated that mycoplasma are responsible for up to 60% of cell culture contamination, causing enormous costs and effort. If a contamination remains undetected, contaminated cultures can endanger scientific data, delay research projects and jeopardise the safety of biopharmaceutical products. Since mycoplasma are too small to detect under the microscope and do not cause turbidity in the growth media it is difficult to detect a contamination. Traditional methods like growth based culture method or DNA staining are slow and unreliable.

At Minerva Biolabs, we understand the critical importance of reliable mycoplasma monitoring. In particular, if the product to be released has a short shelf life (e.g. ATMPs), a rapid method is required to rule out any risk of contamination for the patient. With our Venor® mycoplasma detection kits the testing time can be reduced to three hours.

Over 160 mycoplasma species, including the most common contaminants like M. orale, M. arginini, and A. laidlawii, are specifically detected by amplifying the 16S rRNA coding region in the mycoplasma genome. High specificity is guaranteed by the use of TaqMan® probes. Moreover, the integrated internal and positive controls ensure results integrity and help troubleshoot potential PCR inhibition.

To meet various needs, we offer several variants of mycoplasma assays for conventional and real-time PCR, enabling rapid mycoplasma screening of samples in research and development as well as validated release testing compliant with the European, United States and Japanese Pharmacopeia. A detection limit of less than 10 CFU/ml for all mycoplasma species fulfils the requirements for sensitivity. For product-specific validation we recommend to use our 10CFU™ Sensitivity Standards/100CFU™ Sensitivity Standards that contain irreversibly inactivated mycoplasma.

Key features

  • Comprehensive coverage: Detect >160 mycoplasma species
  • Speed: Time-to-result < 3 hours
  • High sensitivity: detection limit of less than 10 CFU/ml
  • Ease of use: Simple workflows compatible with most common real-time PCR cycler
  • Regulatory compliance: Compliant with EP 2.6.7, USP <1071> and JP G3 (validation report available)
  • Controls included: Internal and positive controls ensure result integrity and help troubleshoot potential PCR inhibition.

For over 25 years, our kits empower researchers, biotech companies, and pharmaceutical manufacturers to safeguard their cell cultures and biopharmaceuticals and ensure regulatory compliance with minimal hands-on time.

Discover our Venor® mycoplasma detection kits here and rely on Minerva Biolabs - a manufacturer with many years of experience and expertise in the field of mycoplasma detection!