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. 2018 Nov;56:29–38. doi: 10.1016/j.biologicals.2018.09.001

Table 7.

Thermal stability of 16/138 stored at elevated temperatures relative to storage at −20 °C.

Exposure
Method Anti-Vi IgG potency relative to −20 °Ca
Duration Temperature Vial 1 Vial 2 GM
8.8 months +4 °C NIBSC ELISA 0.90 0.86 0.88
+20 °C 0.83 0.81 0.82
+37 °C 0.74 0.70 0.72
+45 °C 0.39 0.38 0.38
+4 °C VaccZyme ELISA 0.97 1.03 1.00
+20 °C 0.95 1.05 1.00
+37 °C 0.82 0.96 0.89
+45 °C NLb 0.73 0.73
a

Data produced by Laboratory 5.

b

Non linear.