The present application concerns concentrated protein formulations with reduced viscosity, which are particularly suitable for subcutaneous administration. The application further concerns a method for reducing the viscosity of concentrated protein formulations.

Reduced-viscosity concentrated protein formulations

A liquid aqueous pharmaceutical formulation is described which has a high protein concentration, a pH of between about 4 and about 8, and enhanced stability.

Formulation of human antibodies for treating tnf-alpha associated disorders

The invention provides an aqueous formulation comprising water and a protein, and methods of making the same. The aqueous formulation of the invention may be a high protein formulation and/or may have low levels of conductivity resulting from the low levels of ionic excipients. Also included in the invention are formulations comprising water and proteins having low osmolality.

Protein formulations and methods of making same

Stabilized preparations containing an antibody in a glycine buffer solution and/or a histidine buffer solution; and a process for producing a stabilized protein-containing preparation characterized in that the pH value is controlled with the use of a basic amino acid, a basic amino acid derivative or a salt thereof.

Stabilized antibody-containing preparations

A stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody, polysorbate 80, a buffer which inhibits polysorbate oxidation is described along with methods of making the preparation. Also described are formulations with high antibody concentrations which maintain fixed volumes and which may be used on patients of variable weight.

Immunoglobulin formulation and method of preparation thereof

Histidine-stabilized immunoglobulin preparations and a method for their manufacture are disclosed. The present invention is particularly well suited for stabilization of human gamma globulin (IgG) preparations having a relatively low protein content. Preferred stabilized human gamma globulin preparations comprise about 5 wt-% or less gamma globulin, histidine at a concentration of about 0.025M to about 0.2M, and optionally glycine at a concentration of about 0.05M to about 0.5M. The pH value of the preparations is at least 6.0 but not more than 7.0. A pH value of about 6.4 is most preferred. Conductivity of the preparations is about 2 to about 4 millisiemens at 5° C., preferably about 2.5 to about 3.5 millisiemens at 5° C., and most preferably about 2.7 millisiemens at 5° C.

Histidine stabilized immunoglobulin and method of preparation

Histidine-stabilized immunoglobulin preparations and a method for their manufacturer are disclosed The present invention is particularly well suited for stabilization of human gamma globulin (IgG) preparations having a relatively low protein content Preferred stabilized human gamma globulin preparations comprise about 5 wt-% or less gamma globulin, histidie at a concentration of about 0025M to about 02M, and optionally glycine at a concentration of about 005M to about 05M The pH value of the preparations is at least 60 but not more than 70 A pH value of about 64 is most preferred Conductivity of the preparations is about 2 to about 4 millisiemens at 5°C, preferably about 25 to about 35 millisiemens at 5°C, and most preferably about 27 millisiemens at 5°C

Jennifer A. Nasser

Papers

Histidine stabilized immunoglobulin and method of preparation

Stabilized immunoglobulin and method of preparation

Stabilisiertes Immunoglobulin und Verfahren zu seiner Herstellung

Immunoglobulin stabilised with histidine composition

Immunoglobuline stabilisée et son procédé de préparation