Genentech, Inc.

Xanthe M Lam

Jeffrey L Cleland

Chung C Hsu

David E Overcashier

Janet Yu-Feng Yang

Steven J Shire

James Andya

Sylvia Sau-Yan Wu

Eileen T Duenas

Franklin W Okumu

Rita L Wong

James Q Oeswein

Tue H Nguyen

Michael Frank Powell

Sharon X Wang

Robert P Weissburg

Boonsri Ongpipattanakul

Yan Wu

Wei Ey Li

Zahra Shahrokh

Daniel Kirchhofer

Cecilia Pui Chi Chiu

Linda R De Young

Paul M Moran

Ganesh A Kolumam

Linda R DeYoung

Zehra Shahrokh

Ada Hui

Lin Luis

Monica Kong Beltran

Andrew Peterson

A stable lyophilized protein formulation is described which can be reconstituted with a suitable diluent to generate a high protein concentration reconstituted formulation which is suitable for subcutaneous administration. For example, anti-IgE and anti-HER2 antibody formulations have been prepared by lyophilizing these antibodies in the presence of a lyoprotectant. The lyophilized mixture thus formed is reconstituted to a high protein concentration without apparent loss of stability of the protein.

Protein formulation

The invention provides anti-PCSK9 antibodies, formulations, dosing regimens, and methods of using the same.

Anti-PCSK9 antibodies, formulations, dosing, and methods of use

The invention provides injection vehicles suitable for administering particulate suspensions, such as polymer-based formulations, as well as associated pharmaceutical formulations, articles of manufacture, and kits. Other aspects of the invention included methods for producing and administering pharmaceutical formulations. The injection vehicles of the invention are superior to conventional injection vehicles in that they include a pseudoplastic composition that improves injectability, which facilitates delivery of the desired dose. The injection vehicles of the invention also allow the use of smaller-bore needles than are usually necessary to inject polymer-based formulations, reducing the pain associated with injection of such formulations.

Injection vehicle for polymer-based formulations

NGF microencapsulation compositions having controlled release characteristics, preferably with increased stability, for the NGF component, particularly human recombinant NGF ('rhNGF') are provided that yield enhanced stability of NGF for use in promoting nerve cell growth, repair, survival, differentiation, maturation or function. Methods for making and using such compositions are also provided.

Controlled release microencapsulated NGF formulation

A stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of antibody not subjected to prior lyophilization, a buffer maintaining the pH in the range from about 4.5 to about 6.0, a surfactant and a polyol is described, along with uses for such a formulation.

Antibody formulation

Formulations are provided comprising NGF and acetate-containing buffer from pH 5 to 6 that provide enhanced stability of NGF for use in promoting nerve cell growth, repair, survival, differentiation, maturation or function.

Stabilizing formulation for NGF

NGF microencapsulation compositions having controlled release characteristics, preferably with increased stability, for the NGF component, particularly human recombinant NGF (&ldquo;rhNGF&rdquo;) are provided that yield enhanced stability of NGF for use in promoting nerve cell growth, repair, survival, differentiation, maturation or function. Methods for making and using such compositions are also provided.

A stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody not subjected to prior lyophilization, a buffer maintaining the pH in the range from about 4.5 to about 6.0, a surfactant and a polyol is described, along with uses for such a formulation.

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South San Francisco, CA, United States of America

Xanthe M Lam