Recombinant Protein Drug Testing for Chlamydia Detection

Recombinant protein drugs refer to protein products that originate from animals and plants and are developed through biotechnology research, possessing certain bioactivity and are capable of preventing, treating, and diagnosing human, animal, and plant diseases. Compared with small molecule drugs, recombinant protein drugs have advantages of high activity, high specificity, and low toxicity, which has made them popular among researchers. Currently, recombinant protein drugs are widely used in various fields, such as tumors, autoimmune diseases, metabolic diseases, geriatric diseases, and degenerative diseases. However, in the actual production process of recombinant protein drugs, the quality control of drug production is key to ensuring their safety and effectiveness. In drug quality control, in addition to testing the activity, purity, and sterility of the drug, it is also necessary to conduct mycoplasma testing on recombinant protein drugs.

 

Mycoplasma is a unique microorganism, neither a true bacterium nor a true virus, its size is between bacteria and viruses. In the process of biological pharmaceutical production, especially when using mammalian cells as hosts to prepare recombinant protein drugs, mycoplasma contamination is an important issue, because the presence of mycoplasma may affect the quality and safety of the drug. Therefore, mycoplasma testing of recombinant protein drugs is a necessary quality control step.

 

Common methods of mycoplasma detection include: isolation culture method, indicator cell method, and nucleic acid method. The isolation culture method has a very high detection accuracy and has therefore become the gold standard for mycoplasma detection, but this method 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, inoculates the sample to be tested onto the indicator cells, and observes whether the cells show corresponding changes. This method is suitable for some mycoplasmas that are not easy to cultivate, but the time required for detection is also relatively long. The nucleic acid method is to amplify and detect possible mycoplasmas in the drug sample, thereby judging whether the drug is contaminated. The nucleic acid method is fast, and has high specificity and sensitivity. Currently, this method is relatively widely used for detecting mycoplasma contamination in recombinant protein drugs.

 

Based on our existing experimental platforms, MtoZ Biolabs provide you with one-stop recombinant protein drug mycoplasma detection services. Just tell us your experimental purpose and send the sample, MtoZ Biolabs is responsible for all subsequent projects, including sample processing, machine analysis, data analysis, and project reporting. Feel free to consult.