Methods of treating viral infections by administering an antibody preparation comprising IGG, IGA and IGM
AssigneeBiotest AG
InventorsWolfgang Möller, Dieter Rudnick, Oliver Maneg, Michael Rodemer, Matthias Germer, Veit Braun
Life of this patent
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Abstract
An antibody preparation suitable for intravenous administration in humans includes IgG, IgA and at least 5% IgM antibodies by weight of the total amount of antibodies. The preparation is prepared from human plasma, has specific complement activating activity, and, in an in vitro assay with human serum suitable to determine the ability of the antibody preparation to activate complement unspecifically, the antibody preparation generates substantially no C5a and/or substantially no C3a. The antibody preparation can have medical uses.
Claims20
A method of treatment of a patient suffering from a viral infection comprising administering an antibody preparation to said patient wherein the antibody preparation comprises immunoglobulins IgG, IgA and IgM, wherein at least 15% by weight of the total immunoglobulins are IgM, at least 5% by weight of the total immunoglobulins are IgA and at least 40% by weight of the total immunoglobulins are IgG, wherein the antibody preparation is virus safe with respect to enveloped and non-enveloped virus, has an anticomplementary activity of ≤1 CH 50/mg protein, is stable in liquid form for at least 2 years when stored at 2 to 8° C., wherein the antibody preparation comprises a protein concentration of 40 g/L to 80 g/L, and an immunoglobulin content of greater than 95% of the total protein content.
A method of treatment of a viral infection in a patient comprising administering an antibody preparation to said patient wherein the antibody preparation comprises at least 15% IgM, more than 5% IgA and more than 40% IgG as percentages of the total amount of antibodies, a protein concentration of 40 g/L to 80 g/L, an immunoglobulin content of greater than 95% of total protein concentration, and comprises less than 1.5% aggregates of 1200 KDa or above of the total immunoglobulin content as determined by high performance size exclusion chromatography.
A method of treatment of a viral infection in a patient comprising administering an antibody preparation intravenously to said patient wherein the antibody preparation comprises IgG, IgA and at least 5% IgM antibodies by weight of the total amount of antibodies;
- wherein the preparation is prepared from human plasma;
- wherein the antibody preparation is prepared by a process which is capable of a more than 3 log10 removal of non-enveloped viruses;
- wherein the antibody preparation has specific complement activating activity;
- and wherein, in an in vitro assay with human serum suitable to determine the ability of the antibody preparation to activate complement unspecifically, the antibody preparation generates:
- (i) substantially no C5a, such that the antibody preparation, adjusted to an IgM concentration of 1.72 mg/ml, generates less than 200 ng/ml C5a after 60 minutes of the assay and/or (ii) substantially no C3a, such that the antibody preparation, adjusted to an IgM concentration of 1.72 mg/ml, generates less than 6000 ng/ml C3a after 60 minutes of the assay.
Dependencies are inferred from the claim text.