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. 2019 Mar 15;42:145–156. doi: 10.1016/j.ebiom.2019.03.010

Table 2.

Stability of the PRIMVAC drug product at 25 °C with adjuvant.

TESTS T0 + Alhydrogel® 4 h + Alhydrogel® T0 + GLA-SE 4 h + GLA-SE
Visual appearence White, opalescent w/o visible particles White, opalescent w/o visible particles Slightly brownish, opalescent w/o visible particles Slightly brownish, opalescent w/o visible particles
pH 7.4 7.4 6.4 6.3
Profile by SDS-PAGE Before desorption: no band Before desorption: no band One major band at 100 kDa. Few aggregates. Presence of GLA-SE materials and smears from 37 kDa One major band at 100 kDa. Few aggregates. Presence of GLA-SE materials and smears from 37 kDa
After desorption: One specific band at 100 kDa After desorption: One specific band at 100 kDa
Identity by Western Blot (R and NR conditions) Before desorption: no band Before desorption: no band One specific band at 100 kDa One specific band at 100 kDa
After desorption: One specific band at 100 kDa After desorption: One specific band at 100 kDa
Protein content by BCA Before desorption: ND Before desorption: ND 398 μg/vial 398 μg/vial
After desorption: 96 μg/vial After desorption: 78 μg/vial