IgG, IgA and IgM antibody preparations, method of making and method of use in treatment
AssigneeBiotest AG
InventorsWolfgang Möller, Dieter Rudnick, Oliver Maneg, Michael Rodemer, Matthias Germer, Veit Braun
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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.
Claims17
An antibody preparation suitable for intravenous administration in humans comprising 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.
Dependencies are inferred from the claim text.