Biotest Pharma Gmbh

Association Pour L'essor De La Transfusion Sanguine Dans La Region Du

Detlef Rohm

Michael Kloft

Dominique Bourel

Roland Beliard

Dieter Rudnick

Norbert Kothe

Detlef Piechaczek

Ulf Bethke

Herwald Klein

Magali Holuigue

Peter Byrne

Herve Broly

Ahmed Bouzidi

The invention relates to 2 human monoclonal antibodies of sub-classes IgG1 and IgG3, against the Rhesus D antigen and to a pharmaceutical composition containing a mixture of the said antibodies, more particularly intended for the prophylaxis of the haemolytic disease of the newborn. The invention also relates to the heterohybridoma cell lines that produce these antibodies, which are filed with the 'Deutsche Sammlung von Mikroorganismen und Zellkulturen' under accession numbers DSM AC 2039 and DSM AC 2040.

Human monoclonal anti-rhesus (D) antibodies and cell lines producing same

Method of manufacturing an intravenously tolerable immunoglobulin-G preparation that is free of aggregates, vasoactive substances and proteolytic enzymes and accordingly appropriate for all types of patients, especially immunosuppressed patients, from a starting material that contains immunoglobulin G but from which the coagulation factors have been removed. The starting material is treated with 0.4 to 1.5% by volume of octanoic acid and then chromatographed, especially on an ion or cation exchanger or hydrophobic matrix.

Manufacturing intravenous tolerable immunoglobulin-G preparation

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Darmstadt, Germany

Detlef Rohm