Antibody preparations
AssigneeBiotest AG
InventorsWolfgang Möller, Dieter Rudnick, Oliver Maneg, Michael Rodemer, Matthias Germer, Veit Braun
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AssigneeBiotest AG
InventorsWolfgang Möller, Dieter Rudnick, Oliver Maneg, Michael Rodemer, Matthias Germer, Veit Braun
Estimating the term…
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.
A method of treatment of a patient suffering from a bacterial infection 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, 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 patient suffering from a bacterial infection comprising administering an antibody preparation intravenously 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, comprises less than 1.5% aggregates of 1200 KDa or above of the total immunoglobulin content as determined by high performance size exclusion chromatography, is substantially free of non-enveloped virus, has an anti-complementary activity of less than 0.75 CH50/mg protein, and wherein at least 90% of the antibodies in the preparation are biologically active, as determined by the Eur. Ph. 2.7.9 Test for Fc Function of Immunoglobulin.
A method of treatment of a patient suffering from a bacterial infection comprising administering an antibody preparation intravenously to said patient wherein the antibody preparation comprising:
Dependencies are inferred from the claim text.