Stable liquid formulations of antibodies
AssigneeNovartis AG
InventorsTudor Arvinte, Pierre F Fauquex
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Abstract
The present invention provides stable liquid formulations of antibodies suitable for parenteral administration. Also, provided are aqueous solutions which have high concentrations of therapeutical antibodies which may be used to produce therapeutical liquid formulations. The present invention also relates to uses, such as medical uses, of the stable liquid formulations and processes for the production of the stable liquid formulations.
Claims44
A stable aqueous solution comprising an E25 anti-IgE antibody at a concentration of at least 80 mg/ml, and further comprising acetic acid at a concentration of at least 0.001%.
A stable aqueous solution comprising an E25 anti-IgE antibody at a concentration of at least 80 mg/ml and acetic acid, wherein the stable aqueous solution does not contain sodium acetate.
A process for the preparation of a therapeutic liquid formulation comprising an E25 anti-IgE antibody, wherein in a first step an aqueous solution including an E25 anti-IgE antibody at a concentration of at least 80 mg/ml and acetic acid at a concentration of at least 0.01% is prepared, and, in a second step, at least one pharmaceutically acceptable additive is added to said aqueous solution.
A process for the preparation of a therapeutic liquid formulation comprising an E25 anti-IgE antibody at a concentration of more than 80 mg/ml, wherein
- in a first step an E25 anti-IgE antibody solution in a suitable buffer is concentrated to a concentration of between about 10 mg/ml and 80 mg/ml;
- in a second step, the concentrated solution obtained in the first step is diafiltered with an aqueous solution of acetic acid, optionally containing MgCl2 and/or CaCl2 and/or further suitable additives;
- and,
- in a third step, the solution obtained in the second step is further concentrated to a concentration of more than 80 mg/ml.
A process for the preparation of a therapeutic liquid formulation comprising an E25 anti-IgE antibody at a concentration of more than 80 mg/ml, wherein
- in a first step an E25 anti-IgE antibody solution in a suitable buffer is concentrated to a concentration of between about 10 mg/ml and 80 mg/ml;
- in a second step, the concentrated solution obtained in the first step is diafiltered with an aqueous solution of acetic acid;
- in a third step, the solution obtained in the second step is further concentrated to an intermediate concentration of between about 100 and 150 mg/ml E25 anti-IgE antibody;
- in a fourth step, the intermediate concentrated solution obtained in the third step is diafiltered with an aqueous solution of acetic acid and further containing MgCl2 and/or CaCl2 and/or further suitable additives;
- and,
- in a fifth step, the solution obtained in the fourth step is further concentrated to a concentration of more than 150 mg/ml E25 anti-IgE antibody.
A therapeutic liquid formulation obtained by preparing an aqueous solution including an E25 anti-IgE antibody at a concentration of at least 80 mg/ml and acetic acid at a concentration of at least 0.01%;
- and adding at least one pharmaceutically acceptable additive to said aqueous solution.
A process for the preparation of a therapeutic liquid formulation comprising an anti-IgE E25 antibody, which process comprises adding acetic acid on the last purification step of the preparation of said antibody.
A stable aqueous solution, comprising:
- (i) an E25 anti-IgE antibody at a concentration of at least 80 mg/ml, (ii) acetic acid and (iii) CaCl2 and/or MgCl2.
Dependencies are inferred from the claim text.