发明授权
- 专利标题: Liquid formulation of long-acting human growth hormone conjugate
- 专利标题(中): 长效人生长激素结合物的液体制剂
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申请号: US13809783申请日: 2011-07-14
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公开(公告)号: US09061072B2公开(公告)日: 2015-06-23
- 发明人: Sung Hee Hong , Byung Sun Lee , Dae Seong Im , Jae Min Lee , Sung Min Bae , Se Chang Kwon
- 申请人: Sung Hee Hong , Byung Sun Lee , Dae Seong Im , Jae Min Lee , Sung Min Bae , Se Chang Kwon
- 申请人地址: KR Hwaseong-si
- 专利权人: HANMI SCIENCE CO., LTD
- 当前专利权人: HANMI SCIENCE CO., LTD
- 当前专利权人地址: KR Hwaseong-si
- 代理机构: Sughrue Mion, PLLC
- 优先权: KR10-2010-0067796 20100714
- 国际申请: PCT/KR2011/005194 WO 20110714
- 国际公布: WO2012/008779 WO 20120119
- 主分类号: C07K17/06
- IPC分类号: C07K17/06 ; A61K39/00 ; A61K47/48 ; A61K9/00 ; A61K9/08 ; A61K38/27 ; A61K47/26 ; A61K47/12
摘要:
Disclosed is a liquid formulation of long-acting human growth hormone (hGH) conjugate, free of albumin, which can guarantee the stability of the long-acting hGH conjugate when stored over a long period of time, wherein the long-acting human growth hormone conjugate includes a human growth hormone linked to an immunoglobulin Fc region, and has a prolonged in vivo stability compared to the native form. The liquid formulation of hGH conjugate including a pH 5.0˜6.0 buffer, a sugar alcohol, a salt and a non-ionic surfactant is free of human serum albumin and other hazardous factors which are potentially contaminated with viruses, and can provide excellent storage stability customized for a long-acting hGH conjugate composed of an hGH polypeptide and an immunoglobulin Fc region which has higher molecular weight and in vivo durability, compared to the native.
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