Mycoplasma testing for cell product release

For products kept in culture for more than 48 hours, FDA requires testing for mycoplasma. The USP has approved a mycoplasma procedure that is generally accepted in the USA, Japan and the EU. The test incorporates a mycoplasma assay, and several weeks are required to obtain results. The FDA has been agreeable to the use of alternative methods such as PCR, which is accepted on the EU, or enzyme-based assays, but it may require validation data for their use in product release