Mycoplasma Detection in Recombinant Protein Vaccines

Recombinant protein vaccines are prepared using genetic engineering technology. The preparation process typically involves selecting one or more protein fragments from the target pathogen and inserting the genes for these protein fragments into another organism (such as bacteria or yeast) to express them in large quantities. These recombinant proteins can then be purified and used as the main components of the vaccine. Compared to traditional live or inactivated vaccines, recombinant protein vaccines do not contain live pathogens, making them generally considered safer.

 

Mycoplasma is a unique microorganism that is neither a true bacterium nor a true virus, with a size between bacteria and viruses. In the biopharmaceutical production process, especially when using mammalian cells as hosts to prepare recombinant protein vaccines, mycoplasma contamination is a significant issue because the presence of mycoplasma can affect the quality and safety of the drugs. Therefore, mycoplasma detection in recombinant protein vaccines is a necessary quality control step.

 

Common mycoplasma detection methods include isolation culture method, indicator cell method, and nucleic acid method. The isolation culture method is highly accurate and thus considered the gold standard for mycoplasma detection, but it has certain drawbacks, such as long detection time and limited identification of mycoplasma species. The indicator cell method uses the specific reaction of mycoplasma to certain cells by inoculating the sample onto indicator cells and observing if the cells show corresponding changes. This method is suitable for some mycoplasmas that are difficult to culture, but it also requires relatively long detection times. The nucleic acid method detects mycoplasma by amplifying and identifying its presence in the drug sample, allowing for the determination of contamination. The nucleic acid method is fast, highly specific, and sensitive, and it is currently widely used for detecting mycoplasma contamination in recombinant protein vaccines.

 

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 recombinant protein vaccine mycoplasma detection service. You only need to 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 reports. Free consultation is available!