Abstract: A method is provided for producing a sterile and pyrogen-free column containing coupled protein for use in removing a predetermined substance from the blood of a human subject. The method abrogates sterilization of the finished protein-containing product by providing sterile and pyrogen-free raw materials at each production step. The method provides a pathogen-free, purified solution of protein which binds to a predetermined substance in human blood such as LDL or immunoglobulin. Typically, the protein is anti-human LDL immunoglobulin or anti-human Ig immunoglobulin. The method also provides a sterile and pyrogen-free column matrix material such as an agarose which is chemically activated, either using CNBr and triethylamine or using 1,1'-carbonyldiimidazole.
Type:
Grant
Filed:
May 16, 1995
Date of Patent:
October 6, 1998
Assignee:
Therasorb Medizinische Systeme GmbH
Inventors:
Wolfgang Bohm, Franz A. Bieber, Jutta Muller-Derlich, Alan Barclay, Reiner Spaethe, Michael Bernhard, Christine Kraus