Immunex Corporation

Amgen Inc.

Richard L Remmele, Jr

Wayne Richard Gombotz

Rebecca E McCoy

William Callahan

Dingjiang Liu

Helmut M Sassenfeld

Gayathri Ratnaswamy

Ramil F Latypov

Susan Irene Hershenson

David Brems

Eva Kras

Bruce D Mason

Yatin R Gokarn

Jifeng Zhang

The invention herein described, provides, among other things, self-buffering protein formulations. Particularly, the invention provides self-buffering pharmaceutical protein formulations that are suitable for veterinary and human medical use. The self-buffering protein formulations are substantially free of other buffering agents, stably maintain pH for the extended time periods involved in the distribution and storage of pharmaceutical proteins for veterinary and human medical use. The invention further provides methods for designing, making, and using the formulation. In addition to other advantages, the formulations avoid the disadvantages associated with the buffering agents conventionally used in current formulations of proteins for pharmaceutical use. The invention in these and other respects can be productively applied to a wide variety of proteins and is particularly useful for making and using self-buffering formulations of pharmaceutical proteins for veterinary and medical use, especially, in particular, for the treatment of diseases in human subjects.

Self-buffering antibody formulations

The present invention relates to an aqueous pharmaceutical composition suitable for long-term storage of polypeptides containing an Fc domain of an immunoglobulin, methods of manufacture, methods of administration and kits containing same.

Compositions comprising a P75 tumor necrosis factor receptor/Ig fusion protein

The present invention provides long-term stable formulations of a lyophilized therapeutic peptibody and methods for making a lyophilized composition comprising a therapeutic peptibody.

Lyophilized therapeutic peptibody formulations

Described herein are anti-sclerostin antibody crystals, methods of making such antibody crystals and formulations comprising the antibody crystals.

Antibody formulations

The present invention relates to pharmaceutical compositions comprising a p75 tumor necrosis factor receptor/Ig fusion protein.

Compositions comprising a p75 tumor necrosis factor receptor/Ig fusion protein

Polypeptide formulation

Stable aqueous formulation of a soluble TNF receptor and arginine

The invention provides methods of increasing yields of desired conformation of proteins. In particular embodiments, the invention includes contacting preparations of a recombinant protein with a reduction/oxidation coupling reagent for a time sufficient to increase the relative proportion of a desired configurational isomer.

Increased recovery of active proteins

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Camarillo, CA, United States of America

Richard L Remmele, Jr