Properties of Biotherapeutic Proteins in Long-Term Stability Study
Name | Class | Molecular weight (x10−3) | Structure | Concentration (mg/mL) |
---|---|---|---|---|
Protein A | Fusion protein | 60 | α2 | 3.0 |
Protein B | Monoclonal antibody | 150 | (αβ)2 | 5.0 |
Protein C | Cytokine | 16.2 | α | 5.5 |
Protein D | Fusion protein | 180 | αβ | 50 |
The formulations and protein concentrations correspond to those of the drug manufacturer and were not altered: Protein A—10 mM Na citrate/0.02% Polysorbate 80/5% mannitol (pH 6.5); Protein B—10 mM Na phosphate/145 mM NaCl (pH 7.2); Protein C—10 mM Na glutamate/2% glycine/0.01% Polysorbate 20/1% sucrose (pH 4.3); Protein D—25 mM Na phosphate/100 mM NaCl/1% sucrose (pH 6.3).