Hoffmann-La Roche Inc.

Other

Forschungszentrum Borstel Leibniz Lungenzentrum

Forschungszentrum Borstel Leibniz Lungerzentrum

F. Hoffmann-La Roche Ag

Christian Alexander

Sven Deutschmann

Pierre Lang

Friedrich Von Wintzingerode

Ulrich Zaehringer

Reginald Gorczynski

Jean-Pierre Mach

Ulrich Zahringer

Otto Westphal

Josette Westphal, Legal Representative

Alexander Westphal, Legal Representative

Thierry Walli

Silke Muller

Alfred Hartman

Wolfgang Bessler

Petra Hofmann

Ulrich Vor Dem Esche

Artur J Ulmer

Antonio Verdini

Herein is reported a method for determining bacterial endotoxin at low concentrations in a sample of an antibody (that has been produced using bacterial cells) comprising the following steps in the following order: i) adding magnesium ions to the sample, ii) diluting the sample, iii) dialyzing the sample having a pH-value of 5.7-8.0 against an endotoxin-flee aqueous solution, and iv) determining bacterial endotoxin in the sample using a bacterial endotoxin test, particularly theamoebocyte lysate assay.

Bacterial endotoxin test for the determination of endotoxins

Herein is reported a method for determining bacterial endotoxin at low concentrations in a sample of an antibody (that has been produced using bacterial cells) comprising the following steps in the following order: i) adding magnesium ions to the sample, ii) diluting the sample, iii) dialyzing the sample having a pH-value of 5.7-8.0 against an endotoxin-free aqueous solution, and iv) determining bacterial endotoxin in the sample using a bacterial endotoxin test, particularly theamoebocyte lysate assay.

The present invention relates to a pharmaceutical composition representing a novel immunomodulating principle comprising bacterial endotoxin, fetal hemoglobin or more particularly a heme-free derivative or the &#x3b3;-chain thereof, and optionally, components which are present in the fetal liver in addition to HbF. The composition is delivered to humans in a pharmaceutically acceptable carrier and/or diluent. In accordance with the present invention it was surprisingly found that endotoxin and fetal hemoglobin partial structures display a pronounced synergistic biomedical activity. The biomedical effect of fetal hemoglobin and its partial structures is surprisingly not based on a classical hemoglobin function as an oxygen transporter but related to a modulation of endotoxin-mediated bioactivity. This biomedical activity is surprisingly also observed after oral application of the composition. The composition of the invention finds a variety of applications which have in common the stimulation of the immune system and the reversion in polarization of cytokines and chemokines from a Th2-directed response to a Th1-type response. The proposed applications would therefore include the treatment of allergic conditions, malignancies, chronic infections, autoimmune phenomena and age-related imbalances.

Compositions comprising fetal hemoglobin and bacterial endotoxin and optionally additional fetal liver components

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Borstel, Germany

Christian Alexander