Mycoplasma Testing Of Biopharmaceuticals And ATMP: Current Regulations, Challenges And Trends

As mycoplasmas can be difficult to detect and may lead to the loss of entire production batches, routine testing is essential. The traditional culture method for mycoplasma detection, while sensitive, can take up to 28 days for results and risks introducing contamination into a facility due to the use of live mycoplasma cells as controls.

Alternative, Nucleic Acid Amplification Technique (NAT)-based methods, such as quantitative real-time PCR (qPCR), provide a faster, automated, and more reliable alternative. These methods can produce results in as little as 4 to 6 hours and have been shown to be as sensitive as conventional methods. A comprehensive technical report outlines the advantages of using NAT-based methods and provides recommendations for their validation and implementation in biopharmaceutical and ATMP manufacturing. Download this article to learn more about the benefits of implementing rapid mycoplasma testing.