Bayer Corporation

Fujifilm Diosynth Biotechnologies U.s.a., LLC

Mark David Chavez

Jeffrey Schrimsher

Wytold R Lebing

David Ownby

Min Wan

Woody D Wood

Susan Trukawinski

The present invention generally relates to novel processes for protein purification in high salt solutions such as cell culture broth by increasing the dynamic binding capacity of a resin with the addition of polyethylene glycol.

Increased dynamic binding capacity in ion exchange chromatography by addition of polyethylene glycol

Purification of &agr;-1 proteinase inhibitor (&agr;-1 PI) from aqueous solutions, such as human plasma, is accomplished by precipitation of contaminating proteins from the aqueous solution, followed by dilution of the solution to adjust its conductivity, and passing of the solution through an anion exchange resin. The conductivity of the solution is adjusted so that the &agr;-1 PI binds to the anion exchange resin, while other contaminating proteins and solvent pass through the resin. Further purification may be accomplished by cation chromatography, which takes advantage of the fact that &agr;-1 PI does not bind to the cation column under certain conditions. Some embodiments of the invention also include virus removal and/or inactivation by methods such as nanofiltration and such as contact with a non-ionic detergent. The methods of the present invention result in greater yield, purity, and pathogenic clearance of plasma fractions than known methods.

Method of preparing &agr;-1 proteinase inhibitor

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Raleigh, NC, United States of America

Mark David Chavez