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1. (WO2017017135) IMPROVED BACTERIAL ENDOTOXIN TEST FOR THE DETERMINATION OF ENDOTOXINS

Pub. No.:    WO/2017/017135    International Application No.:    PCT/EP2016/067896
Publication Date: Fri Feb 03 00:59:59 CET 2017 International Filing Date: Thu Jul 28 01:59:59 CEST 2016
IPC: G01N 33/579
Applicants: FORSCHUNGSZENTRUM BORSTEL LEIBNIZ LUNGENZENTRUM
F. HOFFMANN-LA ROCHE AG
HOFFMANN-LA ROCHE INC.
Inventors: ALEXANDER, Christian
DEUTSCHMANN, Sven
LANG, Pierre
VON WINTZINGERODE, Friedrich
ZAEHRINGER, Ulrich
Title: IMPROVED BACTERIAL ENDOTOXIN TEST FOR THE DETERMINATION OF ENDOTOXINS
Abstract:
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 the limulus amoebocyte lysate assay.