Amgen Inc.

Susan Irene Hershenson

Thomas Charles Boone

John David Young

Ellen Ngoi Yin Cheung

Michael P Bevilacqua

David S Collins

Richard L Remmele, Jr

David Brems

Yatin R Gokarn

Eva Kras

Richard Louis Remmele, Jr

Richard Louis Remmele

David N Brems

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

A protein which exhibits a therapeutic effect on inflammation and is useful for treating IL-1-mediated inflammatory diseases, particularly diseases of the joint.

Composition and method for treating inflammatory diseases

The in vivo circulating life and/or absorption of cationic therapeutic proteins, including but not limited to basic proteins such as NT-3 and BDNF, can be increased by generating analogs that have a lower isoelectric point and, preferably, also a lower protein charge relative to the protein of native sequence.

Protein analogs of brain-derived neurotrophic factor

Antibodies against analogs of brain-derived neurotrophic factor

The in vivo circulating life and/or absorption of Neurophic Factor-3 (NT-3) is increased by generating certain substitution analogs of the native protein sequence that result in a lower isoelectric point and charge in relation to NT-3 of native sequence.

Analogs of NT-3

The present invention relates to lyophilized formulations of Stem Cell Factor (SCF) with increased stability. The formulations of lyophilized SCF include amino acid buffers and sucrose. Methods of producing said formulations are also disclosed in the specification.

Stem cell factor formulations and methods

The in vivo circulating life and/or absorption of cationic therapeutic proteins, including but not limited to basic proteins such as NT-3, can be increased by generating analogs that have a lower isoelectric point and, preferably, also a lower protein charge relative to the protein of native sequence.

The in vivo circulating life and/or absorption of the cationic therapeutic protein BDNF can be increased by generating analogs that have a lower isoelectric point and, preferably, also a lower protein charge relative to the protein of native sequence.

Analogs of cationic proteins

Disclosed is a method of preparing a lyophilized stem cell factor (SCF). The method comprises mixing the SCF with histidine and/or glutamic acid and lyophilizing the formulation. Optionally, a bulking agent or an osmolarity regulating agent is included in the formulation prior to lyophilization.

The invention relates to a novel formulation of stem cell factor. The formulation contains histidine, glutamic acid, sucrose and mannitol. The formulation has a pH between 5.0 and 6.0 and has been lyophilized.

Growing community of inventors

Newbury Park, CA, United States of America

Susan Irene Hershenson