Stability study
After the liquid virosome MYM-V202 manufacture and quality controls as described above, it was processed downstream into sublingual tablets (MYM-V212), nasal powder (MYM-V222), and oral powder (MYM-V232). Aliquots of the nasal and oral powder were taken into sealed glass vials, wrapped and double bagged in foil pouches for light and moisture protection. Note that recently, after MACIVIVA project completion, stability was also conducted on Aptar nasal devices loaded with powder and similar results were obtained. Sealed aluminum blisters of sublingual tablets were directly placed into the storage room without additional packaging. Freshly prepared liquid and solid vaccine forms were split into two distinct lots: one for animal immunizations and one for quality controls. Lots were stored at 4?°C, 25?°C/60% RH, and 40?°C/75% for 1 and 3 months, then powder forms were stored at -20?°C and liquid form stored at 4?°C until analyses. Samples were analyzed by HPLC for vaccine content for P1, rgp41, and 3M-052, together with particle size analysis by NTA and measurement of the moisture content for solid vaccine dosages. Animals were immunized with vaccine samples kept at 4?°C after being exposed to various environmental conditions or analyzed as described above.
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