The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Date of Patent:
Dec. 02, 2025

Filed:

Jun. 05, 2020
Applicant:

Biotest Ag, Dreieich, DE;

Inventors:

Katharina Heim, Dreieich, DE;

Marcus Gutscher, Dreieich, DE;

Assignee:

Biotest AG, Dreieich, DE;

Attorney:
Primary Examiner:
Int. Cl.
CPC ...
G01N 33/68 (2006.01); A61K 35/16 (2015.01); G01N 33/569 (2006.01);
U.S. Cl.
CPC ...
G01N 33/6854 (2013.01); A61K 35/16 (2013.01); G01N 33/56944 (2013.01);
Abstract

The present invention relates to the field of immunotherapeutics. It provides a method for characterisation and quality control, in particular for determining the potency of an immunoglobulin composition comprising immunoglobulins derived from a plurality of human donors, the method comprising contacting the immunoglobulin composition with pneumolysin, adding erythrocytes to the immunoglobulin composition and determining lysis of the erythrocytes. The invention also provides a corresponding use of pneumolysin, as well as a kit and composition useful in said method. The method can be used for quality control of immunoglobulin concentrate, e.g., of an IgM-containing immunoglobulin composition comprising IgM, IgA and IgG antibodies, and in a method of preparing an immunoglobulin composition. The immunoglobulin compositions obtainable from said method may be used, e.g., in the treatment of pneumonia, e.g., severe community-acquired pneumonia, which may be caused, e.g., by


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