发明名称 |
STERILE AND PYROGEN-FREE COLUMNS COUPLED TO PROTEIN FOR BINDING AND REMOVAL OF SUBSTANCES FROM BLOOD |
摘要 |
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. |
申请公布号 |
EP0804734(A4) |
申请公布日期 |
1998.10.07 |
申请号 |
EP19950920516 |
申请日期 |
1995.05.15 |
申请人 |
THERASORB MEDIZINISCHE SYSTEME GMBH |
发明人 |
BOEHM, WOLFGANG;BIEBER, FRANZ, A.;MUELLER-DERLICH, JUTTA;BARCLAY, ALAN;SPAETHE, REINER;BERNHARD, MICHAEL;KRAUS, CHRISTINE |
分类号 |
G01N33/50;A61K35/14;A61M1/36;C07K1/22;C07K14/31;C07K14/315;C07K16/06;G01N30/14;G01N30/46;G01N30/88;G01N33/53;G01N33/538;G01N33/569;G01N33/68;(IPC1-7):G01N33/544;G01N33/545;G01N33/552;C12N11/14;C12N11/10;C12N11/08;C07K17/08;C07K17/10;C07K17/14 |
主分类号 |
G01N33/50 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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