TABLE 3

List of candidate formulations for sIPV lyophilization and percent recovery of D-antigen following lyophilizationa

Formulation codeBulking
agent/stabilizer
BufferSugarpHSurfactantSE
HPLC
recovery
(%)
ELISA
recovery
(%)
F12.5% glycine10 mM Tris-HCl1% sucrose80.1% pluronic F688985
F25% mannitol10 mM histidine1% sorbitol7None1819
F35% mannitol10 mM histidine1% sorbitol70.1% pluronic F687478
F45% mannitol10 mM histidine1% sorbitol70.5% pluronic F689195
F55% mannitol10 mM histidine1% sorbitol71.0% pluronic F689291
F65% mannitol10 mM histidine1% sucrose70.1% pluronic F686588
F7r5% mannitol10 mM histidine1% sucrose70.5% pluronic F687273
F85% mannitol10 mM histidine1% sorbitol70.01% polysorbate 209190
F95% mannitol10 mM histidine1% sucrose70.01% polysorbate 209091
F105% mannitol10 mM histidine1% sorbitol70.1% polysorbate 207681
F115% mannitol10 mM histidine1% sorbitol70.5% polysorbate 207778
F125% mannitol10 mM histidine1% sorbitol70.05% polysorbate 207582
F135% mannitol10 mM histidine1% sucrose70.1% polysorbate 208074
F142.5% glycine10 mM histidine1% sucrose70.1% pluronic F684276
F152.5% glycine10 mM histidine1% sorbitol60.1% pluronic F6859N.T.
F162.5% glycine10 mM histidine1% sucrose60.1% pluronic F6858N.T.
F175% mannitol10 mM histidine1% sorbitol60.1% pluronic F6861N.T.
F182.5% glycine10 mM histidine1% sorbitol60.1% pluronic F6865N.T.
  • a MgSO4 (1 mM) was used as a stabilizer for all formulations. N.T., not tested.