Amgen Inc.

Christopher James Sloey

Tiansheng Li

Jason Ko

Sekhar Kanapuram

Chio Mui Chan

Elaheh Binabaji

Huanchun Cui

Camille Vergara

Neeraj Jagdish Agrawal

Pavan K Ghattyvenkatakrishna

Camille Gleason

The present invention relates to stable aqueous protein formulations. In particular, disclosed herein are therapeutic protein formulations suitable for parenteral administration having one or more antioxidants.

Aqueous antibody formulation stabilized by antioxidants for parenteral administration

Provided herein are formulations of PCSK9-binding polypeptides, such as those comprising evolocumab, that comprise N-acetyl arginine and have reduced viscosities when compared to formulations lacking N-acetyl arginine. Provided herein are also methods of formulating such compositions that are advantageous in that they conserve certain components. Such formulations comprising PCSK9-binding polypeptides can be administered to patients to treat and/or prevent PCSK9-related diseases, conditions, and disorders.

Low-viscosity, high concentration evolocumab formulations and methods of making the same

A method for reducing the viscosity of a pharmaceutical formulation is provided that utilizes a viscosity-reducing concentration of an excipient selected from the group consisting of the n-acetyl arginine, n-acetyl lysine, n-acetyl proline and mixtures thereof in combination with a therapeutiv protein. A stable pharmaceutical formulation is also provided.

Lyophilized powder configured for reconstitution as a liquid pharmaceutical formulation with reduced viscosity and method of preparing thereof

Provided herein are excipients capable of effectively reducing the viscosity of polypeptide (e.g., therapeutic polypeptide) formulations. The viscosity reducing excipients are dipeptides containing arginine at the carboxy terminus and N-acetylated serine or N-acetylated proline at the N-terminus. Glutamate-arginine is also disclosed as a viscosity-reducing dipeptide. Among the disclosed methods, methods of reducing the viscosities of such formulations are also provided.

N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides

Methods for reducing the viscosity of liquid pharmaceutical formulations comprising therapeutic proteins

Aqueous formulation of erythropoiesis stimulating protein stabilised by antioxidants for parenteral administration

A method of stabilizing an aqueous protein or antibody formulation is disclosed herein. Additionally, stable pharmaceutical formulations are contemplated which comprise a biologically active protein, a destabilizing concentration of preservative and a stabilizing concentration of osmolyte.

Pharmaceutical formulations

A stable pharmaceutical formulation is provided that comprises a biologically active protein and an excipient selected from carnitine, creatine or creatinine.

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Newbury Park, CA, United States of America

Christopher James Sloey