Amgen Inc.

Amgen Research Gmbh

Arnold McAuley

Pavel V Bondarenko

Cornelius Pompe

Douglas Rehder

Dirk Chelius

Masazumi Matsumura

Sekhar Kanapuram

Jun Zhang

Joon Hoi Huh

Pavan K Ghattyvenkatakrishna

Bharadwaj Jagannathan

Devrishi Goswami

Ananthakrishnan G Sethuraman

Lingwen Cui

Jeff Abel

Michael Treuheit

Michael Schneider

Pavel Bondarenko

The present invention provides an improved pharmaceutical composition for storage and administration comprising (a) a bispecific antibody construct comprising a first domain binding to a target cell surface antigen and a second domain binding to a second antigen, wherein the bispecific antibody construct is present at a concentration in the range from about 0.5 μg/ml to 20 mg/ml, (b) a preservative at a concentration effective to inhibit the growth of microbes, and (c) a diluent wherein bispecific antibody construct is stable and recoverable.

Pharmaceutical composition comprising bispecific antibody constructs for improved storage and administration

The invention provides a formulation including a buffer having a pH less than 6.0, a divalent cation between about 5-200 mM, an excipient comprising a sugar or polyol and an effective amount of a therapeutic polypeptide. Also provided is a method of stabilizing a polypeptide. The method includes contacting a therapeutic polypeptide with a concentration of divalent cation between about 5-150 150 mM in a buffer having a pH less than 6.0 and an excipient comprising a sugar or polyol.

Stable polypeptide formulations

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Moorpark, CA, United States of America

Arnold McAuley