Methods for Stabilizing Protein Solutions

• US 20070249812A1
• Filed: 10/08/2004
• Published: 10/25/2007
• Est. Priority Date: 10/09/2003
• Status: Active Grant

• Current Assignee: Chugai Seiyaku Kabushiki Kaisha (Roche Holding AG)
• Original Assignee: Chugai Seiyaku Kabushiki Kaisha (Roche Holding AG)
• Inventors: Igawa, Tomoyuki, Sekimori, Yasuo, Hayasaka, Akira
• Granted Patent: US 7,803,914 B2
• Time in Patent Office: Days
• US Class Current: 530/387.100
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61P 37/02 Immunomodulators
• CPC Class Codes: C07K 16/00 Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies antibodies with enzymatic activity, e.g. abzymes C12N9/0002

Abstract

The present inventors examined use of citric acid buffers for suppressing cryoprecipitation of IgM at a pH range and salt concentration suitable for storing IgM. As a result, the present inventors discovered that citric acid buffers significantly suppress cryoprecipitation.

Claims

1. A method for stabilizing a protein at low temperature, wherein the method comprises adding a citric acid buffer to a solution comprising the protein.

2. The method of claim 1, wherein the protein is stabilized by suppressing cryoprecipitation.

3. The method of claim 1, wherein the protein is IgM.

4. The method of claim 1, wherein pH of the solution comprising the protein is 5 to 8.