Amgen Inc.

Coherus Biosciences, Inc.

Amgen Research (munich) Gmbh

Amgen Research Gmbh

Sekhar Kanapuram

Christopher James Sloey

Chio Mui Chan

Elaheh Binabaji

Huanchun Cui

Mark Cornell Manning

Jun Liu

Neeraj Jagdish Agrawal

Cornelius Pompe

Jun Zhang

Ramil F Latypov

Arnold McAuley

Joon Hoi Huh

Pavan K Ghattyvenkatakrishna

Balakumar Thangaraj

Michael Schneider

Michael Treuheit

Jeff Abel

Lingwen Cui

Ananthakrishnan G Sethuraman

Devrishi Goswami

Bharadwaj Jagannathan

Ramil Latypov

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

The present invention provides an improved pharmaceutical composition for storage and administration comprising (a) a bispecific antibody construct comprising a first domain binding to a target cell surface antigen and a second domain binding to a second antigen, wherein the bispecific antibody construct is present at a concentration in the range from about 0.5 μg/ml to 20 mg/ml, (b) a preservative at a concentration effective to inhibit the growth of microbes, and (c) a diluent wherein bispecific antibody construct is stable and recoverable.

Pharmaceutical composition comprising bispecific antibody constructs for improved storage and administration

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

A stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of aflibercept, wherein the formulation is free of organic co-solvent and/or free of buffer; methods for making such a formulation; and methods of using such a formulation.

Stable aqueous formulations of aflibercept

The present invention provides novel and stable pharmaceutical compositions comprising bispecific single chain antibody constructs, cyclodextrins and a buffer.

Pharmaceutical composition comprising bispecific antibody constructs

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Thousand Oaks, CA, United States of America

Sekhar Kanapuram