Rapid MycoTOOL Real-Time Test for Mycoplasma Detection -
PCR instead of Cell Culture
Mycoplasmas are a common source of contamination in biopharmaceutical production, cultivation of stem cells, and tissue engineering.
Mycoplasma contamination in the manufacturing process of ‘classical‘ biopharmaceutical products (also known as biologics or large molecules) and of cell-based medicinal products (also known as cell therapy products or advancedtherapy medicinal products, ATMP) poses a potential health risk to patients.
Mycoplasmas can affect virtually every cell culture parameter with often only minor visible effects, creating an uncontrollable environment that is undesirable in the pharmaceutical and cell therapy industry. Therefore, regulatory agencies require manufacturers to test their biopharmaceutical products and ATMP to ensure the absence of mycoplasmas in released products.
The MycoTOOL Mycoplasma Real-Time PCR Test is a mycoplasma detection kit accepted for biopharmaceutical release testing by the FDA, EMA and further authorities for fast, easy, and reliable Mycoplasma testing.
- Detect over 140 Mollicute species
including Spiroplasma and Acholeplasma using universal primer designs
- Sensitivity you can count on
<10 CFU/ml for all validated species - click here to download poster
- Reproducibility you can depend on
Avoid false positives by utilizing carryover prevention with dUTP and UNG
- Time savings you can plan on
Results in a few hours instead of waiting for the outcome of a 28-day culture test