A fast detection of Mycoplasma contamination in Advanced Therapy Medicinal Products (ATMP) is very important due to the short shelf life of this type of product. With the use of the Microsart® ATMP Mycoplasma the testing time can be reduced from weeks to just 3 hours. Additionally, the utilization of a TaqMan® probe adds high specificity to the PCR system and minimizes the result interpretation. The Microsart® ATMP Mycoplasma has been effectively validated according EP 2.6.7 in combination with EP 2.6.21 with respect to the detection limit for all listed Mycoplasma species, specificity and robustness for autologous cell transplants (e.g. chondrocytes).
The Microsart® ATMP Mycoplasma kit can be easily implemented because no specific hardware is needed.
The kit can be used with any type of real-time PCR cycler able to detect the fluorescence dyes FAM™ and ROX™. The kit contains all essential components in a function tested ready-to-use master mix including the polymerase.