Validation and international regulatory experience for a mycoplasma touchdown PCR assay.


A PCR assay was developed to monitor rFVIII production fermenters for mycoplasma contamination. The method uses a simple extraction procedure followed by a qualitative "touchdown" (TD) PCR protocol with primers specific to the 16S rRNA gene. The method has the capacity to detect a wide range of mycoplasma species. Validation was performed according to ICH… (More)
DOI: 10.1016/j.biologicals.2009.11.006