Sterile and pyrogen-free columns containing coupled protein for binding and removal of substances from blood

US5817528A · kind A · utility

Assignee

• Therasorb Medizinische Systeme GmbH · DE

Inventors

• Wolfgang Bohm · Alzenau, DE
• Franz Bieber · Unterschleißheim, DE
• Jutta Muller-Derlich · Hersbruck, DE
• Alan Barclay · Tubize, BE
• Reiner Spaethe · Starnberg, DE
• Michael I. Bernhard · Summit, US
• Christine Kraus · Schwarzheide, DE

Key dates

• Filing date: May 16, 1995
• Grant date: Oct 6, 1998
• Expiry date: May 16, 2015

Classification

• Technology area (CPC Y): Emerging Cross-Sectional Technologies
• CPC primary: Y10S530/813
• WIPO field: Measurement
• WIPO sector: Instruments

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.