Antibody and protein formulations

Patent metadata

Field	Value
Publication number	US-9592297-B2
Application number	US-201313843780-A
Country	US
Kind code	B2
Filing date	Mar 15, 2013
Priority date	Aug 31, 2012
Publication date	Mar 14, 2017
Grant date	Mar 14, 2017

Abstract

Provided are salt-free antibody and other protein formulations that are substantially isosmotic and of low viscosity. Also provided are methods for the treatment of diseases using the disclosed formulations.

First claim

What is claimed is:

1. A salt-free anti-TFPI antibody formulation, comprising:
a. 10 mM to 30 mM histidine,
b. 50 ppm to 200 ppm of a non-ionic surfactant,
c. 88 mM to 292 mM of a sugar or sugar alcohol selected from mannitol, dextrose, glucose, trehalose and sucrose,
d. 10 mM to 50 mM arginine,
e. 0 mM to 50 mM lysine,
f. 0 mM to 133 mM glycine or alanine
g. 0 mM to 10 mM methionine, and
h. 1 mg/ml to 150 mg/ml of anti-TFPI human IgG 2 antibody having a light chain comprising the amino acid sequence of SEQ ID NO: 1 and a heavy chain comprising the amino acid sequence of SEQ ID NO:2, and wherein said anti-TFPI antibody formulation has a pH of pH 4.0 to pH 6.0, and wherein said anti-TFPI antibody formulation contains substantially no inorganic salt.

Assignees

• Bayer Healthcare Llc

Inventors

• Xiang Jun
• Ma Xinghang

Classifications

• A61K2039/505

  comprising antibodies · CPC title

• C07K2317/94

  Stability, e.g. half-life, pH, temperature or enzyme-resistance · CPC title

• C07K16/18

  against material from animals or humans · CPC title

• A61K47/22

  Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones · CPC title

• A61K39/39591

  Stabilisation, fragmentation · CPC title