Sterile and pyrogen-free columns containing coupled protein for

Details Sterile and pyrogen-free columns containing coupled protein for Sterile and pyrogen-free columns containing coupled protein for

1995-05-16

1998-10-06

Naff, David M.

Chemistry: analytical and immunological testing

Involving an insoluble carrier for immobilizing immunochemicals

Carrier is organic

435 2, 435174, 435176, 435178, 435180, 436518, 436524, 436531, 530402, 530413, 530810, 530811, 530813, 530815, G01N 33544, C12N 1100, C07K 1700, C07K 1710

Patent

active

058175288

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. 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.

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patent: 5281579 (1994-01-01), Estep
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