Genentech, Inc.

Chung C Hsu

Jeffrey L Cleland

Steven J Shire

Xanthe M Lam

James Andya

David E Overcashier

Janet Yu-Feng Yang

Sylvia Sau-Yan Wu

Bradley Richard Snedecor

Andrew Reginald Clark

Hoc M Nguyen

Sylvia S Wu

Andrew J Walsh

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

A method of treating a mammal with a formulation comprising an antibody which binds IgE as described.

Treating a mammal with a formulation comprising an antibody which binds IgE

Disclosed herein is a method for the preparation of sodium chloride formulations having a substantially uniform particle size suitable to ensure the dispersible properties for inhalation into the lungs of a subject. The formulations thus prepared are also the subject of this disclosure. The method involves jet milling coarse sodium chloride in one or preferably two or more procedures using air pressure suitable to produce particles having a significant fraction that are less than about 7 microns in size. Immediately following the milling, the particles are vacuum dried in an oven using a temperature and time suitable to cure the product to prevent substantial aggregation over time.

Preparation of sodium chloride aerosol formulations

Methods are provided for the preparation of liposomes utilizing aerosolization of a solution comprising bilayer-forming materials and optional additional molecules onto an aqueous surface, the aerosolization being mist spraying through a frequency-generated vibrating nozzle.

Method for preparing liposomes

A formulation for proteins is provided that comprises a lyophilized mixture of a protein, a water-soluble etherified cellulose in an amount that upon reconstitution of the formulation will be sufficient to form a gel, and an excipient to facilitate rehydration of the gel and to maintain protein integrity during storage of the lyophilized gel product. When reconstituted to a gel, this formulation can be applied, for example, to tissue in need of treatment.

Reconstitutable lyophilized protein formulation

Enzyme-catalyzed synthetic reactions having otherwise unfavorable equilibria are facilitated by recovery of polypeptides by electrodialysis. A process of preparing polypeptides is provided that can be operated continuously to produce high yields of enriched polypeptides without recourse to post-synthetic product manipulations heretofore employed that are expensive and present a risk of residual toxic by-products. The invention is applied to advantage in the preparation of alpha-L-aspartyl-L-phenylalanine lower alkyl esters.

Growing community of inventors

Los Altos Hills, CA, United States of America

Chung C Hsu