Mycoplasma is widely distributed in nature, and it is easy to cause pollution in the process of cell culture. It is a necessary item in the quality control of biological products. The traditional culture method of mycoplasma takes a long time, which is difficult to meet the process monitoring requirements of raw materials and excipients, and brings challenges to the release and detection of cell therapy products. Foreign pharmacopoeia (USP,EP, and JP) have included Nucleic acid amplification techniques for detection of mycoplasma, which has not been formally included in domestic pharmacopoeia, but CDE documents support enterprises to develop new detection methods of mycoplasma. After verification, it is used for release detection.