Plasmaselect Gmbh Teterow

Therasorb Medizinische Systeme Gmbh

Franz A Bieber

Reiner Spaethe

Jutta Muller-Derlich

Wolfgang Bohm

Robert Koll

Christine Kraus

Michael Bernhard

Alan Barclay

The invention provides a method to prevent or ameliorate hyperacute or acute rejection of a human donor organ transplanted to a human recipient. Hyperacute rejection would normally occur after a human subject receives a transplanted human organ against which the subject has preformed anti-HLA antibodies. Acute rejection occurs when the recipient of a human organ forms antibodies against that organ after transplant. The invention method comprises passing the plasma of the recipient over a sterile and pyrogen-free column coupled to anti-human immunoglobulin antibodies which bind to and remove a significant portion of the immunoglobulin from the subject's plasma.

Ameliorating immunological rejection of allograft

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. The sterile and pyrogen-free, activated matrix material and the pathogen-free, purified protein solution are combined under aseptic conditions to effect the coupling of the protein to the matrix material, and the protein-coupled matrix material is filled under aseptic conditions into a sterile and pyrogen-free housing to produce a sterile and pyrogen-free column.

Sterile and pyrogen-free columns containing coupled protein for binding

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Unterschleissheim, Germany

Franz A Bieber