Bayer Corporation

Bayer Healthcare LLC

Talecris Biotherapeutics, Inc.

Christopher J Stenland

James Rebbeor

Marina N Korneyeva

Valery Novokhatny

Douglas C Lee

Jonathan S Strauss

Steve R Petteway

Jeffrey A Yuziuk

Scott A Cook

Richard Scott Rosenthal

Christopher A Dadd

Jonathan D Kent

Jarrett C Terry

Rita T Bradley

Nathan C Jones

Disclosed is both a process for producing a reversibly inactive acidified plasmin by activating plasminogen and a process for producing a purified plasminogen. The produced plasmin is isolated and stored with a low pH-buffering capacity agent to provide a substantially stable formulation. The purified plasminogen is typically purified from a fraction obtained in the separation of immunoglobulin from Fraction II+III chromatographic process and eluted at a low pH. The reversibly inactive acidified plasmin may be used in the administration of a thrombolytic therapy.

Process for the production of a reversibly inactive acidified plasmin composition

A method of sanitizing chromatographic media is provided. The method includes contacting the media with an acidic chaotropic agent, at low temperature and low pH. The method provides pathogen removal and/or inactivation, including viral inactivation in particular embodiments.

Sanitization of chromatographic media

Disclosed is a method for separating prions from biological materials. The method includes adding a polyalkylene glycol, such as polyethylene glycol, to a solution of the biological material such that a precipitate containing the prion is formed. This precipitate is then separated from the solution of biological material, thereby removing prions. Biological materials include biologically derived fluids, such as cerebrospinal fluid, biological samples, such as brain homogenates, blood plasma fractions, and aqueous solutions of recombinantly produced products. The disclosed method provides an effective process for the removal of these infectious materials from the biological materials, which may be further processed to provide the therapeutic compositions.

Method of separating prions from biological materials

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Cary, NC, United States of America

Christopher J Stenland