Select The Best Analyte: A Guide To Effective Mycoplasma Testing

By Sharon Rouw, product manager, Thermo Fisher Scientific

Mycoplasma testing is essential to providing a safe, high-quality therapeutic to patients as Mycoplasma contamination has the potential to alter DNA, RNA, and protein synthesis, resulting in threats to product efficacy and patient safety. Due to these risks, Mycoplasma testing is a requirement from most global regulatory bodies for GMP-grade pharmaceuticals comprised of cellular material or manufactured in mammalian cell cultures. However, beyond the risks to patient safety and regulatory compliance, failure to detect Mycoplasma contamination can lead to a loss of time, money, and raw materials, or even facility shutdown.

There are a number of approaches available to conduct robust Mycoplasma testing. Historically, the process has been conducted with live Mycoplasma, however, more recently, there has been an increase in the leveraging of molecular testing methods, including qPCR assays that provide accurate, sensitive, and rapid Mycoplasma detection. Download the full whitepaper to explore the different Mycoplasma testing techniques and the advantages they offer to support confident reporting and project needs.