Cellin Technologies offers the rapid and reliable detection of mycoplasma contamination in cell cultures and various cell therapy medicinal products. We detect mycoplasma using a commercial validated PCR test in compliance with cGMP.
The replacement of traditional culture method of Mycoplasma analysis with a PCR-based method has several advantages, mainly in the aspect of reduced time (from weeks to only 3 hours) and cost.
The fast detection of mycoplasma contamination is particularly important for companies producing cell theray products due to the short shelf life of this type of articles.
Using this highly sensitive and specific test, we can detect less than 10 cfu/ml for all Mycoplasma species mentioned in the European Pharmacopoeia.
RAPID DETECTION OF MYCOPLASMA ACCORDING TO EUROPEAN PHARMACOPOEIA CHAPTER 2.6.7
The test is validated according to EP 2.6.7 Mycoplasmas in combination with EP 2.6.21 Nucleic Acid Amplification Techniques with respect to the detection limit for all listed Mycoplasma species, specificity and robustness.
GMP VALIDATED PCR TEST
HOW TO SEND A SAMPLE
If you are interested in sending us a sample, please contact us for more information.