Regeneron Pharmaceuticals, Inc.

Cordelia Lighting, Inc.

Daniel B Dix

Kelly Frye

Kenneth S Graham

Eric Steven Furfine

Scott M Walsh

Susan Kautz

Xiaolin Tang

Douglas Kamen

Katherine Bowers

Chimanlall Goolcharran

Ning Li

Leu-Fen H Lin

John Mattila

Hanne Bak

Chen Li

William Markis

Huan Cao Nguyen

Stanley J Wiegand

Kanghong Zhang

Jingtai Cao

Ivan Borisovich Lobov

James Madden

Seth Chang

Dwight David Santiago

Karen W Chu

Robert L Vitti

Saurabh Wadhwa

Kristine A Erickson

Terra Potocky

Edmond Daniels

Renuka Sivendran

Goolcharran Chimanlall

Douglas E Kamen

Disclosed herein are methods for overfilling primary packaging components, and drug products prepared according to those methods. The methods may include introducing a volume of a formulated drug substance into a primary packaging component having a nominal volume, where the volume of the formulated drug substance is greater than the nominal volume of the primary packaging component. In some cases, the primary packaging component may be a prefillable syringe.

Devices and methods for overfilling drug containers

Ophthalmic formulations of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist are provided suitable for intravitreal administration to the eye. The ophthalmic formulations include a stable liquid formulation and a lyophilizable formulation. Preferably, the protein antagonist has an amino acid sequence of SEQ ID NO:4.

VEGF antagonist formulations suitable for intravitreal administration

The present invention provides pharmaceutical formulations comprising a human antibody that specifically binds to human interleukin-6 receptor (hIL-6R). The formulations may contain, in addition to an anti-hIL-6R antibody, at least one amino acid, at least one sugar, and/or at least one non-ionic surfactant. The pharmaceutical formulations of the present invention exhibit a substantial degree of antibody stability after storage for several months.

Stabilized formulations containing anti-interleukin-6 receptor (IL-6R) antibodies

The present disclosure provides a stable protein composition containing a surfactant and having less than 400 subvisible particles of 10 microns or greater diameter per container, or less than 10,000 subvisible particles of 2 microns or greater per container. A method of manufacturing such a stable protein composition is disclosed, which includes a unit of operation that removes or decreases an esterase activity that degrades the surfactant. The unit of operation may be hydrophobic interaction chromatography or filtration, mixed mode chromatography, or the like.

Process for reducing subvisible particles in a pharmaceutical formulation

The present invention provides pharmaceutical formulations comprising a human antibody that specifically binds to human interleukin-4 receptor (hIL-4R). The formulations may contain, in addition to an anti-hIL-4R antibody, at least one amino acid, at least one sugar, or at least one non-ionic surfactant. The pharmaceutical formulations of the present invention exhibit a substantial degree of antibody stability after storage for several months.

Stabilized formulations containing anti-interleukin-4 receptor (IL-4R) antibodies

Formulations of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist are provided including a pre-lyophilized formulation, a reconstituted lyophilized formulation, and a stable liquid formulation. Preferably, the fusion protein has the sequence of SEQ ID NO:4.

Citrate buffered VEGF antagonist formulations

The present invention provides pharmaceutical formulations comprising a human antibody that specifically binds to human proprotein convertase subtilisin/kexin type 9 (PCSK9). The formulations may contain, in addition to an anti-PCSK9 antibody, at least one amino acid, at least one sugar, or at least one non-ionic surfactant. The pharmaceutical formulations of the present invention exhibit a substantial degree of antibody stability after storage for several months.

Stabilized formulations containing anti-PCSK9 antibodies

The present invention provides methods for treating, preventing or reducing the severity of an eye disease. The methods of the present invention comprise administering to a subject in need thereof a therapeutic composition comprising an angiopoietin-2 (Ang-2) inhibitor such as an anti-Ang-2 antibody in combination with a vascular endothelial growth factor (VEGF) antagonist (e.g., aflibercept).

Methods and formulations for treating vascular eye diseases using aflibercept and nesvacumab

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Lagrangeville, NY, United States of America

Daniel B Dix