Figure 5.
Effect of combining excipients to further improve the stability of MeRu during drying and storage in dried state on LCP discs. (A) A two-step excipient combination screening strategy was used (Steps 1 and 2), (B) Me and Ru viral infectivity titer log loss during Step 1 screening, and (C) Me and Ru viral infectivity titer log loss during Step 2 screening. Log loss values are relative to a control sample (frozen liquid bulk stored at −80°C). MeRu was formulated with different combinations of excipients in 10 mM phosphate buffer, pH 6.8, dried onto LCP discs at a target titer of 102.02 CCID50/disc for each virus, stored for two weeks at 25°C in the dried state, and viral titers were measured by infectivity RT-qPCR assay. Error bars represent the propagated error of standard deviations from three replicate runs (quadruplicate experiments for each rep run). (*) indicates MeRu candidate formulations selected for further evaluation in storage stability studies (see Figure 6–8)