Rapid Methods for Detecting Mycoplasma Contamination in the Manufacture of Vaccines, Including Pandemic Influenza Vaccines, and Other Biological Products

September 22 - 23, 2008
Hilton Washington DC North/Gaithersburg
620 Perry Pkwy.
Gaithersburg, MD 20877

Workshop Goals and Objectives

The purpose of the public workshop was to provide a forum on recent scientific and technical achievements in the development of rapid methods for mycoplasma testing during the manufacture of vaccines and other biological products. Such discussion may help to assess how these methods compare with currently used methods. Expedited manufacture may be of particular importance to public health during an influenza pandemic. FDA wanted to explore the use of alternative methods for detecting mycoplasma contamination in the manufacture of vaccines, including pandemic influenza vaccines, and other biological products. Alternative methods that allow detection of mycoplasma in a shorter period, as compared to the current methods, could expedite the manufacture of vaccines and other biological products. The workshop was aimed at: (1) Identifying promising rapid method(s) for further validation to demonstrate equivalency or superiority to methods currently used for mycoplasma testing during the manufacture of vaccines and other biological products and (2) providing information that may lead to collaborative studies with FDA on testing for mycoplasma.

Agenda

Presentations

• Technical Report on Alternative Methods for Mycoplasma Testing, Kurt Brorson, Ph.D. (PPT, 45 KB)
• Rapid Methods for Detecting Mycoplasma Contamination in the Manufacture of Vaccines, Including Pandemic Influenza Vaccines, & Other Biological Products, Dr. Rajesh K. Gupta (PPT, 243 KB)