Mycoplasma Testing In Monoclonal Antibody Production

What are the significant risks of mycoplasma contamination in bioproduction processes involving mammalian cell culture or animal-derived materials? Mycoplasmas can disrupt cellular metabolism, potentially compromising the quality of biotherapy products and patient safety. This study discusses two common methods for monitoring mycoplasmas: the culture-based growth test and the PCR-based nucleic acid test (NAT). It highlights the Applied Biosystems™ MycoSEQ™ Plus Mycoplasma Detection Kit, a PCR-based method for detecting mycoplasmas in various bioproduction materials and processes. The kit offers accurate results on the presence or absence of mycoplasma DNA, complying with regulatory guidance. The note also describes how this sensitive detection level can be achieved using genomic DNA from various Mycoplasma species and either automated or manual sample preparation protocols. The study is particularly relevant for a Chinese Hamster Ovary (CHO) cell-based monoclonal antibody (mAb) production workflow.