TABLE I

Properties of Biotherapeutic Proteins in Long-Term Stability Study

NameClassMolecular weight (x10−3)StructureConcentration (mg/mL)
Protein AFusion protein60α23.0
Protein BMonoclonal antibody150(αβ)25.0
Protein CCytokine16.2α5.5
Protein DFusion protein180αβ50
  • 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).