Scientific Publications by FDA Staff
Am Pharm Rev 2011 May-Jun;14(4):37370
Historical Overview of Mycoplasma Testing for Production of Biologics
Chandler DKF, Volokhov DV, Chizhikov VE
This review summarizes the evolution of mycoplasma testing methods as well as the historical development of requirements and recommendations for testing of vaccines and biologics produced in cell substrates. Although newly emerged molecular technologies provide a real possibility to expedite mycoplasma testing, the historical experience accumulated during evaluation and implementation of mycoplasma testing methods may be useful for the identification of challenges associated with the comparability between different methods, particularly when comparable tests rely on detection of different biological features of mycoplasmas. Even though mycoplasma contamination during production of biological products has been recognized for many years, a global consensus regarding the most appropriate testing methods for biological products has not yet been reached, as evidenced by the variations in the regulatory and compendial requirements and guidance recommendations.
|Category: Journal Article, Review|
|Includes FDA Authors from Scientific Area(s): Biologics|
|Entry Created: 2011-10-04||Entry Last Modified: 2012-08-29|