abstract |
A high concentration monoclonal antibody preparation is provided. A high concentration monoclonal antibody preparation suitable for subcutaneous administration by a prefilled syringe is provided. A formulation comprising a spray-dried monoclonal antibody having a concentration of about 200 mg / mL or more suspended in a non-aqueous suspension vehicle, wherein the suspension vehicle has a viscosity of less than about 20 centipoise and a sliding force of about 20 Newtons or less A formulation having an average particle size of about 2 to about 30 microns. Further included is a subcutaneous administration device having the formulation, a method of making the formulation, a method of making a product comprising the suspension formulation, the use of the formulation in the preparation of a medicament, and a method of treating a patient with the formulation. [Selection] Figure 2 |