Table 1.
Summary of the Formulation Conditions
Base Buffera | pHb | Excipientc | Storage Conditions | Methods |
---|---|---|---|---|
Initial Screening of pH and Additives | ||||
Na-citrate | 3.0 | 100 mM NaCl, 0.25 M sucrose, 0.01% Tween 80 | Initial/no storage; 40°C, 4 days; 2 mg/mLd | DLS, DSF |
Glycine | 3.5 | |||
Na-acetate | 4.0 | |||
Na-acetate | 4.5 | |||
Na-acetate | 5.0 | |||
Succinate | 5.5 | |||
Histidine | 6.0 | |||
Histidine | 6.5 | |||
Imidazole | 7.0 | |||
Glycyl–glycine | 8.0 | |||
Glycine | 9.0 | |||
Glycine | 10.0 | |||
Stability Studies Under Accelerated Storage Conditions | ||||
Na-citrate | 3.3 | 100 mM NaCl, 0.25 M sucrose, 0.05% Tween 80 | Initial/no storage; 40°C, 8 weeks; 12 mg/mLd | SAXSe, UV280 nm, SE-HPLC, LabChip |
Na-acetate | 5.0 | |||
Histidine | 6.5 | |||
Na-phosphate | 7.4 | |||
Tris–HCl | 8.5 | |||
Stability Studies Under Normal Storage Conditions | ||||
Histidinef | 6.5 | 0.25 M sucrose | Initial/no storage; 5°C, 8 weeks; 25°C, 8 weeks; 2 mg/mLd | SE-HPLC, iCE |
Na-phosphateg | 7.4 | 100 mM NaCl |
Final concentration of the base buffers was 50 mM.
Measured at room temperature.
Excipients were included respectively to each of the base buffers.
Antibody concentration during storage.
Only the samples at initial time point were measured by SAXS.
Formulation A.
Formulation B.