SAFENSURE™ Mycoplasma DNA Sample Preparation Kit (Magnetic beads)

During the production of biological products (cell isolation, modification, and proliferation), contamination by mycoplasma poses potential risks to patients. Therefore, it is crucial to ensure that the final products are free from mycoplasma contamination during release testing. Traditionally, assessing whether biological products have been contaminated relied on conventional microbiological culture procedures using liquid media and agar media (culture method or indicator cell culture method). However, with the advancement of Biopharmaceuticals and Advanced Therapy Medicinal Products (ATMPs), culture-based methods no longer meet the rapid release requirements.