IPC분류정보
| 국가/구분 |
United States(US) Patent
등록
|
| 국제특허분류(IPC7판) |
|
| 출원번호 |
US-0752189
(2013-01-28)
|
| 등록번호 |
US-9463241
(2016-10-11)
|
| 우선권정보 |
FR-03 04388 (2003-04-09) |
|
발명자
/ 주소 |
- Bardat, Annie
- Begin, Edith
- Khandoudi, Nassirah
- Just, Olivier
- Chtourou, Sami
- Schmitthaeusler, Roland
|
| 출원인 / 주소 |
- LABORATOIRE FRANCAIS DU FRACTIONNEMENT ET DES BIOTECHNOLOGIES
|
| 대리인 / 주소 |
Birch, Stewart, Kolasch & Birch, LLP
|
| 인용정보 |
피인용 횟수 :
0 인용 특허 :
46 |
초록
▼
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
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.
대표청구항
▼
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 consi
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. 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. 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. 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. 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. 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).
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