Biotest Ag

Biotest Pharma Gmbh

Zarske, Gisbert

Wolfgang Moeller

Dieter Rudnick

Oliver Maneg

Michael Kretschmar

Michael Rodemer

Matthias Germer

Norbert Kothe

Veit Braun

Detlef Piechaczek

Achim Hannappel

Herbert Dichtelmueller

Eckhard Flechsig

Alexander Moehlenkamp-Roettger

A process for the preparation of pharmaceutically acceptable immunoglobulin compositions from plasma-derived immunoglobulin fractions which allows the parallel preparation of immunoglobulin compositions enriched in IgG, IgM and IgA. In this process, immunoglobulin contained in Cohn fraction I/II/III or Kistler Nitschmann fraction A+I is resolubilized at conductivities of at least 1 mS/cm, and following removal of contaminating protein the resolubilized immunoglobulin is subjected to anion exchange chromatography to obtain IgG- and IgM/IgA-enriched immunoglobulin compositions. The IgG-enriched immunoglobulin composition is further subjected to treatment with a cation exchange material to obtain an immunoglobulin composition having a reduced properdin content.

Process for preparing immunoglobulin compositions

A process is provided for the preparation of an immunoglobulin composition from a plasma fraction having immunoglobulins, and antibody preparations prepared utilizing the process.

Process for preparing an immunoglobulin composition

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.

Antibody preparations

This invention relates to a process for the production of a von Willebrand factor preparation, hydroxylapatite being used as a chromatography medium.

Production of a von Willebrand factor preparation using hydroxylapatite

The invention relates to a method for separating fibronectin from plasma fractions by adjusting a pH value of less than 5.4 such that fibronectin is precipitated and extracted from the solution.

Process for removing fibronectin from plasma fractions

This invention relates to a process for the production of a von Willebrand factor preparation having a high specific activity, hydroxylapatite being used as a chromatography medium.

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Oberursel, Germany

Wolfgang Moeller