With the advent of rapid mycoplasma detection, regulatory agencies have been stringently requiring comparisons of any developed rapid method to the compendial-derived methods. Recently, both the FDA and EMA have required comparability studies for every unique matrix, as filed, for any rapid mycoplasma detection method used to determine whether mycoplasma are present within the product. These studies are necessary to determine the Limit of Detection, the robustness, and the specificity of the rapid method for each matrix as per USP <1223> and Ph. Eur. 5.1.6. Each matrix is different, and may require a different approach to fulfilling the requirements set down by the agencies.

In this webinar, we will discuss:

• The rapid qPCR methods available at Eurofins: Thermofisher’s MycoSEQ and Biomeriuex’s BIOFIRE®
• The regulations the agencies refer to
• Decisions to determine the best approach for a matrix to be validated on a rapid mycoplasma detection method

Presenter:

	Dr. Jonathan Demick Principle Scientist Eurofins BioPharma Product Testing
Dr. Demick is the principle scientist within the Mycoplasma services department, and oversees the Rapid Mycoplasma testing that supports the needs of our bio/pharmaceutical clients. With 15 years’ experience in molecular biology and a decade in an industrial setting, Dr. Demick is the subject matter expert for the rapid mycoplasma testing. Specific expertise includes qPCR, RT-PCR and ddPCR based methods. Dr. Demick earned his B.S. from Beloit College, M.S. from UW-Madison and his PhD in Biochemistry and Molecular Biology from the University of Georgia.
	Christopher Smith Manager of Mycoplasma Services Eurofins BioPharma Product Testing
Mr. Smith is the Manager of Mycoplasma Services for Eurofins Biopharma Product Testing. The Mycoplasma Service Team is responsible for testing samples for mycoplasma, using compendial methods as well as NAT methods. His team’s work ensures that samples are tested according to USP, EP, and JP regulations for the presence of mycoplasma. Mr. Smith graduated from the Pennsylvania State University and has worked for Eurofins for 19 years.