Determining How to Set up a Comparability Study to Validate a Matrix for Rapid Mycoplasma Detection Testing

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

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