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filingDate 2020-06-05-04:00^^<http://www.w3.org/2001/XMLSchema#date>
inventor http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_0364b526e51ca6ef84c64fb2bf80ca74
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publicationDate 2021-12-02-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber AU-2020287911-A1
titleOfInvention Method and kit for testing potency of immunoglobulin compositions
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 Streptococcus pneumoniae.
priorityDate 2019-06-07-04:00^^<http://www.w3.org/2001/XMLSchema#date>
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