Evaluation of a candidate International Standard for Meningococcal Serogroup C polysaccharide

Last updated on 22-8-2019 by Anonymous (non vérifié)

Sci. report, recommendat°, guidance doc., directive, monograph



Meningococcal serogroup C (MenC) plain polysaccharide (PS) and conjugate vaccines are primarily evaluated by physicochemical methods to ensure that batches are consistently manufactured. As different assays are employed to quantify the MenC PS content of final formulations and bulk intermediaries, there is a need for an International MenC PS Standard to calibrate internal references used in the different laboratories. Twelve laboratories from nine different countries participated in a collaborative study to assess the suitability and determine the MenC PS content of a candidate Internationa…

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