Stable liquid formulations of antibodies
OwnerTudor Arvinte, Pierre Francois Fauquexinventors
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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.
Claims49
A stable aqueous solution comprising an antibody at a concentration of at least 50 mg/ml, and further comprising at least one acidic component.
A nasal spray comprising the aqueous solution as claimed in any preceding claim.
A slow release formulation comprising the aqueous solution as claimed in any preceding claim.
A delivery system which contains the aqueous solution as claimed in any preceding claim, selected from the group of single use injection syringes or inhalation devices.
Use of an acidic component for the preparation of an aqueous solution comprising an antibody having a concentration of at least 50 mg/ml.
A process for the preparation of a therapeutical liquid formulation comprising an antibody, wherein in a first step an aqueous solution including an antibody at a concentration of at least 50 mg/ml and at least one acidic component 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 therapeutical liquid formulation comprising an antibody at a concentration of more than 50 mg/ml, wherein
- in a first step an antibody solution in a suitable buffer is concentrated to a concentration of between about 10 mg/ml and about 50 mg/ml;
- in a second step, the concentrated solution obtained in the first step is diafiltered with an aqueous solution of at least one acidic component, 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 50 mg/ml.
A process for the preparation of a therapeutical liquid formulation comprising an antibody at a concentration of more than 50 mg/ml, wherein
- in a first step an antibody solution in a suitable buffer is concentrated to a concentration of between about 10 mg/ml and about 50 mg/ml;
- in a second step, the concentrated solution obtained in the first step is diafiltered with an aqueous solution of at least one acidic component;
- in a third step, the solution obtained in the second step is further concentrated to an intermediate concentration of between about 100 and about 200 mg/ml, preferably between about 100 and about 150 mg/ml;
- in a fourth step, the intermediate concentrated solution obtained in the third step is diafiltered with an aqueous solution of at least one acidic component 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.
A process for the preparation of a therapeutical liquid formulation comprising an antibody, which process comprises adding an acidic component on the last purification step of the preparation of said antibody.
Dependencies are inferred from the claim text.