Zymogenetics, Inc.

Seattle Genetics, Inc.

Grifols Therapeutics Inc.

Talecris Biotherapeutics, Inc.

Shan Jiang

Damon L Meyer

Richard I Senderoff

Hui Li

Mary Wallace

Thomas P Zimmerman

Valery Novokhatny

Jeffrey D Meyer

James D Colandene

James Colandene

Kent Amsberry

Disclosed are formulations, including both liquid and lyophilized formulations, comprising a benzodiazepine antibody-drug conjugate (ADC) and a cyclodextrin. Also disclosed are methods of purifying mixtures comprising benzodiazepine antibody-drug conjugates and process drug-related impurities.

Cyclodextrin and antibody-drug conjugate formulations

The present invention provides a fibrinolytic composition useful as a therapeutic for administration to a patient having a thrombotic occlusion. In one aspect of the present invention, the fibrinolytic composition comprises a reversibly inactivated acidified serine protease substantially free of a plasminogen activator, a low buffering capacity buffer, and optionally, a stabilizing agent. In another aspect of the invention, the fibrinolytic composition of the present invention comprises a reversibly inactivated acidified plasmin substantially free of a plasminogen activator, a low buffering capacity buffer, and optionally, a stabilizing agent.

Reversibly inactivated acidified plasmin composition

Disclosed are formulations, including both liquid and lyophilized formulations, comprising a benzodiazepine anti-body-drug conjugate (ADC) and a cyclodextrin. Also disclosed are methods of purifying mixtures comprising benzodiazepine anti-body-drug conjugates and process drug-related impurities.

Stabilized thrombin compositions, processes for preparing them, and kits comprising them are disclosed. The compositions comprise thrombin, a bacteriostatically effective amount of benzyl alcohol or chlorobutanol, and 0.10%-5.0% (w/v) sucrose in aqueous solution. The compositions are stable when stored at 2&#xb0; C.-8&#xb0; C. for four weeks or more.

Stabilized thrombin compositions

A method of treating a subject, the method including administring a composition that includes a reversibly inactivated acidfied plasmin substantially free of a plasminogen activator, in a low buffering capacity buffer, wherein the composition is a solution suitable for pharmacenutical use that can be raised to physiological pH by adding no more than about 5 volumes of serum to the solution relative to a volume of the solution.

Reversibly inactivated acidified plasmin

Compositions comprising thrombin and methods of preparing them are disclosed. The composition may be in the form of an aqueous solution at pH 5.7-7.4 consisting essentially of 0.1 mg/mL to 5.0 mg/mL thrombin, 2% to 4% (w/v) sucrose, 3.5% to 5% (w/v) mannitol, 50 mM to 300 mM NaCl, 0-5 mM CaCl, 0.03% to 1% (w/v) of a surfactant or high-molecular-weight polyethylene glycol, and a physiologically acceptable buffer, or may be in lyophilized form.

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Sammamish, WA, United States of America

Shan Jiang