Design and Development of a High-Throughput Platform for Rapid Microbe Identification and Automatic Data Management

Cell cultures are being used increasingly for the manufacture of biopharmaceutical products. Contamination of these cell cultures by mycoplasma is a serious problem, as it potentially compromises the safety of the drugs being produced. Therefore, biopharmaceutical production must comply with different legal requirements and regulatory bodies all over the world. Greiner Bio-One has developed a new test kit for the identification of mycoplasma species in biological materials. CytoCheck (R) has been validated under GMP conditions in accordance with the legal guidelines and has been shown to reach comparable sensitivity and specificity as the cell culture and the indicator cell culture method.