Stabilising formulation for immunoglobulin G compositions in liquid form and in lyophilised form

• US 8,388,954 B2
• Filed: 04/08/2004
• Issued: 03/05/2013
• Est. Priority Date: 04/09/2003
• Status: Active Grant

• Current Assignee: Laboratoire francais du Fractionnement et des Biotechnologies, Yeda Research and Development Co. Ltd. (Weizmann Institute of Science)
• Original Assignee: Laboratoire francais du Fractionnement et des Biotechnologies
• Inventors: Bardat, Annie, Begin, Edith, Khandoudi, Nassirah, Just, Olivier, Chtourou, Sami, Schmitthaeusler, Roland
• Primary Examiner(s): Kim, Yunsoo
• Application Number:
  US10/552,314
• Publication Number:
  US 20070036779A1
• Time in Patent Office: 3,253 Days
• Field of Search: None
• US Class Current: 424/130.1
• CPC Class Codes: A61K 39/395 Antibodies agglutinins A61K38/36 ; as drug carriers A61K47/50; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
• CPC Class Codes: A61K 39/39591 Stabilisation, fragmentation

Abstract

This invention is related to a stabilizing formulation for immunoglobulins G compositions comprising a sugar alcohol, glycine and a non-ionic detergent, which is suitable for the stabilization of immunoglobulins G compositions in liquid form and in lyophilized form. The invention also relates to an immunoglobulins G composition in liquid form or in lyophilized form comprising said stabilizing formulation.

Claims

1. A stabilizing formulation consisting of mannitol, glycine and a non-ionic detergent, suitable for the stabilisation of an immunoglobulin G composition in liquid form and in lyophilised form, wherein the concentration of mannitol is between 30 g/l and 50 g/l, and wherein the concentration of glycine is between 7 g/1 and 10 g/l.

2. An immunoglobulin G composition in liquid form, consisting of immunoglobulins G, water and the stabilising formulation according to claim 1.

3. An immunoglobulin G composition in lyophilised form, consisting of immunoglobulins G and the stabilising formulation according to claim 1.

4. The immunoglobulin G composition according to claim 2, wherein the composition includes an amount of polymers less than 0.3% after a 6 months storage period at room temperature.

5. The immunoglobulin G composition according to claim 3, wherein the composition includes an amount of polymers less than 0.3% after a 12 months storage period at room temperature of for 6 months at 40°

C.

6. The immunoglobulin G composition according to claim 1, wherein the composition includes an amount of dimers less than 7% after a 24 months storage period at 4°

C.