The homogeneity of each batch produced was tested after the lyophilisation step. Each technique proposed in the trial was assessed to analyse several samples chosen at random from the batch production according to ISO 13528: three samples from 2009 to 2013, and then ten samples (since 2012 for negative batches and since 2014 for positive batches) were analysed using all the techniques included in the proficiency test to ensure homogeneity, meaning that positive samples all tested positive and negative samples all tested negative. All the batches used in this study were validated accordingly. One negative batch was excluded after the proficiency test had been carried out due to later detection of the presence of RNA contamination. This batch was used in 2017 and excluded from the evaluation and not therefore included in this study.

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