Table 1.
Formulations classified based on excipients and drying methods.
Table 2.
Residual moisture content of dried Infliximab formulations.
Fig 1.
A. T = 0 Non-reducing SDS-PAGE analysis of reconstituted Infliximab samples. M: Dual color protein standard, 1: commercial Infliximab, 2: Infliximab (AIMM), Freeze-dried (vials) 3: sucrose-based (F1), 4: sucrose-inulin (F2), 5: sucrose-dextran (F3), Freeze-dried (Lyoguard trays) 6: sucrose-inulin (L2), 7: sucrose-dextran (L3), Spray–dried 8: sucrose-inulin (S1), 9: sucrose-dextran (S2). B.T = 0 Reducing SDS-PAGE of reconstituted Infliximab samples. M: Dual color protein standard, 1: commercial Infliximab, 2: Infliximab (AIMM), Freeze-dried (vials) 3: sucrose-based (F1), 4: sucrose-inulin (F2), 5: sucrose-dextran (F3), Freeze-dried (Lyoguard trays) 6: sucrose-inulin (L2), 7: sucrose-dextran (L3), Spray–dried 8: sucrose-inulin (S1), 9: sucrose-dextran (S2).
Fig 2.
A. T = 1 month (60°C) gel filtration runs of reconstituted Infliximab samples. Commercial Infliximab (Remicade) stored at 4°C shown in black. Samples dried in sucrose based buffer shown in blue. Samples dried with sucrose-inulin excipients shown in red. Samples dried with sucrose-dextran based excipient shown in orange. B. T = 1 month (60°C) Non-reducing SDS-PAGE analysis of reconstituted Infliximab samples stored at 60°C. M: Dual color protein standard, 1: commercial Infliximab (stored at 4°C), Freeze-dried (vials) 2: sucrose-based (F1), 3: sucrose-inulin (F2), 4: sucrose-dextran (F3), Freeze-dried (Lyoguard trays) 5: sucrose-based (L1), 6: sucrose-inulin (L2), 7: sucrose-dextran (L3), Spray–dried 8: sucrose-inulin (S1), 9: sucrose-dextran (S2). C. T = 1 month (60°C) Reducing SDS-PAGE analysis of reconstituted Infliximab samples stored at 60°C. M: Dual color protein standard, 1: commercial Infliximab (stored at 4°C, Freeze-dried (vials) 2: sucrose-based (F1), 3: sucrose-inulin (F2), 4: sucrose-dextran (F3), Freeze-dried (Lyoguard trays) 5: sucrose-based (L1), 6: sucrose-inulin (L2), 7: sucrose-dextran (L3), Spray–dried 8: sucrose-inulin (S1), 9: sucrose-dextran (S2).
Table 3.
The percentage of antibody aggregates determined by SEC present in samples after storage at 60°C for 1 month.
In case of non-stressed sample, material was stored at 2–8°C.
Fig 3.
A. T = 0 TNF binding assay of reconstituted freeze-dried in vials Infliximab formulations. Control: Infliximab (AIMM, stored at 4°C), Freeze-dried (vials): sucrose-based (F1), sucrose-inulin (F2) and sucrose-dextran (F3). B. T = 0 TNF binding assay of reconstituted freeze-dried in Lyoguard trays Infliximab formulations. Control: Infliximab (AIMM, stored at 4°C), Freeze-dried (Lyoguard trays): sucrose-inulin (L2) and sucrose-dextran (L3). C.T = 0 TNF binding assay of reconstituted spray-dried Infliximab formulations. Control: Infliximab (AIMM, stored at 4°C), Spray-dried: sucrose-inulin (S1) and sucrose-dextran (S2).
Table 4.
The IgG concentrations observed by IgG ELISA for Infliximab samples.
Fig 4.
A.T = 1 month (60°C) TNF binding assay of reconstituted freeze-dried in vials Infliximab formulations after storage for 1 month at 60°C. Control: Infliximab (AIMM, stored at 4°C), Freeze-dried (vials): sucrose-based (F1), sucrose-inulin (F2) and sucrose-dextran (F3). B.T = 1 month (60°C) TNF binding assay of reconstituted freeze-dried Lyoguard trays Infliximab formulations after storage for1 month at 60°C. Control: Infliximab (AIMM, stored at 4°C), Freeze-dried (Lyoguard trays): sucrose-inulin (L2) and sucrose-dextran (L3). C. T = 1 month (60°C) TNF binding assay of reconstituted spray-dried Infliximab formulations after storage for1 month at 60°C. Control: Infliximab (AIMM, stored at 4°C), Spray–dried: sucrose-inulin (S1) and sucrose-dextran (S2).