Grifols Worldwide Operations Limited

Grifols Therapeutics Inc.

Bayer Healthcare LLC

Talecris Biotherapeutics, Inc.

James Rebbeor

Thomas P Zimmerman

Charles Miller

Anthony Klos

Eric Allgaier

Kevin Wee

Michelle StPeter

Kelly Glancy

Jonathan S Strauss

Christopher J Stenland

Marina N Korneyeva

Jeffrey A Yuziuk

Valery Novokhatny

Jennifer Audrey Hunt

Edward Koepf

Scott A Cook

Richard Scott Rosenthal

Rita T Bradley

Christopher A Dadd

Jonathan D Kent

Jarrett C Terry

Myles Lindsay

Nathan C Jones

Rebecca Silverstein

Dennis McBRIDE

Anthony Caronna

Kenya Stokes

George Grady

A method for obtaining Alpha-1 Proteinase Inhibitor for obtaining highly-concentrated Alpha-1 Proteinase Inhibitor (A1PI) includes preparing a solution of A1PI by concentrating an initial solution of A1PI by tangential flow filtration (TFF) against water. The final concentration of A1PI in the concentrated solution is at least 110 mg/ml. The TFF can be carried out against water for injection (WFD).

Method for obtaining Alpha-1 proteinase inhibitor

Compositions include highly concentrated Alpha-1 Proteinase Inhibitor (A1PI) in a concentration greater than or equal to 100 mg/ml. Pharmaceutical compositions can be prepared from these compositions. The pharmaceutical compositions can be suitable for subcutaneous administration. The highly concentrated A1PI solutions can be obtained by single-pass tangential flow filtration (SPTFF).

Composition comprising highly-concentrated Alpha1 proteinase inhibitor and method for obtaining thereof

Compositions include highly-concentrated Alpha-1 Proteinase Inhibitor (A1PI) in a concentration greater than or equal to 100 mg/ml. Pharmaceutical compositions can be prepared from these compositions. The pharmaceutical compositions can be suitable for subcutaneous administration. The highly-concentrated A1PI solutions can be obtained by single-pass tangential flow filtration (SPTFF).

Composition comprising highly-concentrated &#x3b1;1 proteinase inhibitor and method for obtaining thereof

Composition comprising highly-concentrated ALPHA1 proteinase inhibitor and method for obtaining thereof

Compositions and methods for preparing plasminogen, in particular recombinant plasminogen, and compositions and methods of utilizing same for preparing plasmin are provided.

Compositions, methods and kits for preparing plasminogen and plasmin prepared therefrom

Disclosed is both a method for preparing a plasminogen and a method for preparing a reversibly inactive acidified plasmin by activating the plasminogen. The prepared 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 prepared plasmin is isolated and stored with a low pH-buffering capacity agent to provide a substantially stable formulation. The reversibly inactive acidified plasmin may be used in the administration of a thrombolytic therapy.

Composition and method for preparing plasminogen

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

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Garner, NC, United States of America

James Rebbeor