Antibody Drug Mycoplasma Detection

Antibody drugs are a type of biological product, commonly used in the treatment of various complex diseases, including autoimmune diseases, inflammatory diseases, and cancer. These drugs are produced in cell culture systems through complex biotechnology, usually involving mammalian cell lines, such as CHO (Chinese Hamster Ovary) cells. However, there is a risk of bacterial, viral, or mycoplasma contamination during production, especially mycoplasma, a tiny bacteria without a cell wall that can pass through regular bacterial filtration systems and is difficult to detect in cell culture. Because mycoplasma contamination can potentially affect the safety and efficacy of the produced antibody drugs, strict mycoplasma detection becomes extremely important.

 

Common methods for mycoplasma detection include: isolation culture method, indicator cell method, and nucleic acid method. The detection accuracy of the isolation culture method is very high, thus it has become the gold standard for mycoplasma detection, but this method also has certain drawbacks, the detection time is too long, and the types of mycoplasma that can be identified are limited. The indicator cell method uses the specific reaction of mycoplasma to certain cells, the test samples are inoculated onto the indicator cells, and the cells are observed for any corresponding changes, this method is suitable for some mycoplasmas that are difficult to culture, but the detection time required is also relatively long. The nucleic acid method is to amplify and detect the possible mycoplasma in the drug sample to determine whether the drug is contaminated. The nucleic acid method is fast in detection, and also has high specificity and sensitivity, and is currently widely used for the detection of mycoplasma contamination in antibody drugs.

 

MtoZ Biolabs provides customers with drug quality research services that comply with global pharmaceutical regulations. Based on our existing experimental platform, we provide you with a one-stop antibody drug mycoplasma detection service, if you just tell us your experimental purpose and send the samples, MtoZ Biolabs is responsible for all subsequent projects, including sample processing, experimental analysis, data analysis, and project reporting. Free consultation is welcome.