Using an alternative methodology for the detection of Mycoplasma requires validation and demonstration of comparability to reference standards. A PDA Task Force of experts has developed the PDA Technical Report No. 50, Alternative Methods for Mycoplasma Testing to help your analytical lab feel confident in the use of alternative methods.
The report focuses on non-culture testing methodology, including Nucleic Acid Amplification Technique (NAT) assays and enzyme activity based assays. Representatives of the U.S. FDA and the U.S. Pharmacopeia contributed to the report. The report provides information about existing assays and compendial Methods like NAT based methods and non Nat based methods and describes assay procedures, validation of assays, comparability with reference methods and possible applications.
You can also order the Technical Report.
Axel H. Schroeder
On behalf of the European Compliance Academy