Method for stabilising an immunoglobulin G composition in liquid form

• US 9,463,241 B2
• Filed: 01/28/2013
• Issued: 10/11/2016
• Est. Priority Date: 04/09/2003
• Status: Active Grant

• Current Assignee: Laboratoire francais du Fractionnement et des Biotechnologies, Laboratoire français du fractionnement et des biotechnologies
• Original Assignee: Laboratoire francais du Fractionnement et des Biotechnologies
• Inventors: Khandoudi, Nassirah, Bardat, Annie, Begin, Edith, Just, Olivier, Chtourou, Sami, Schmitthaeusler, Roland
• Primary Examiner(s): Kim, Yunsoo
• Application Number:
  US13/752,189
• Publication Number:
  US 20130202585A1
• Time in Patent Office: 1,352 Days
• Field of Search: None
• US Class Current: 1/1
• 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 method of stabilising a polyclonal immunoglobulin G composition in liquid form obtained directly by fractioning of human plasma, said method comprising combining said polyclonal immunoglobulin G (IgG) composition with a stabilising formulation for IgG compositions, wherein the formulation consists of a sugar alcohol, glycine, and a non-ionic detergent.

4. The method of stabilising a polyclonal immunoglobulin G composition according to any one of claims 1 to 3, wherein the formulation consists in the said sugar alcohol, glycine and non-ionic detergent.

5. The method of stabilising a polyclonal immunoglobulin G composition according to claim 4, wherein the sugar alcohol is mannitol.

6. The method of stabilising a polyclonal immunoglobulin G composition according to claim 5, wherein the concentration of mannitol is between 30 g/l and 50 g/l.

7. The method of stabilising a polyclonal immunoglobulin G composition according to claim 4, wherein the concentration of glycine is between 7 g/l and 10 g/l.

8. The method of stabilising a polyclonal immunoglobulin G composition according to claim 4, wherein the concentration of the non-ionic detergent is between 20 and 50 ppm.

9. The method of stabilising a polyclonal immunoglobulin G composition according to claim 1, wherein the composition includes an amount of polymers less than 0.3% after a 6 month storage period at room temperature.

11. The method of stabilising a polyclonal immunoglobulin G composition according to any one of claims 1 to 3, wherein the composition includes an amount of dimers less than 7% after a 24 month storage period at 4°

C.

12. The method of stabilizing a polyclonal immunoglobulin G composition according to any one of claims 1 to 3, wherein the formulation consists of a sugar alcohol in a concentration of between 30 g/l and 50 g/l, glycine in a concentration of between 7 g/l and 10 g/l, and a non-ionic detergent.

13. The method of stabilizing a polyclonal immunoglobulin G composition according to any one of claims 1 to 3, wherein the formulation consists of a sugar alcohol in a concentration of between 30 g/l and 50 g/l, glycine in a concentration of between 7 g/l and 10 g/l, and a non-ionic detergent in a concentration of between 20 and 50 ppm.

14. The method of stabilizing a polyclonal immunoglobulin G composition according to any one of claims 1 to 3, wherein the formulation consists of mannitol, glycine, and a non-ionic detergent.

15. The method of stabilizing a polyclonal immunoglobulin G composition according to any one of claims 1 to 3, wherein the formulation consists of 50 g/l mannitol, 10 g/l glycine, and 50 ppm polysorbate 80 (non-ionic detergent).

16. The method of stabilizing a polyclonal immunoglobulin G composition according to any one of claims 1 to 3, wherein the formulation consists of 50 g/l mannitol, 10 g/l glycine, and 50 ppm octoxinol 10 (non-ionic detergent).

2. A method of stabilising a polyclonal immunoglobulin G composition in lyophilised form, said method comprising combining said polyclonal immunoglobulin G composition with a stabilising formulation for IgG compositions, wherein the formulation consists of a sugar alcohol, glycine, and a non-ionic detergent.

10. The method of stabilising a polyclonal immunoglobulin G composition according to claim 2, wherein the composition includes an amount of polymers less than 0.3% after a 12 month storage period at room temperature for 6 months at 40°

C.

3. A method of stabilising a polyclonal immunoglobulin G composition in liquid form obtained after reconstitution in a suitable aqueous medium of an immunoglobulin G composition in lyophilised form, said method comprising combining said polyclonal immunoglobulin G composition with a stabilising formulation for IgG compositions, wherein the formulation consists of a sugar alcohol, glycine, and a non-ionic detergent.