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公开(公告)号:IL224225A
公开(公告)日:2018-07-31
申请号:IL22422513
申请日:2013-01-14
Applicant: HANMI SCIENCE CO LTD , SE CHANG KWON , SUNG MIN BAE , SUNG HEE HONG , BYUNG SUN LEE , DEA SEONG IM , JEA MIN LEE
Inventor: SE CHANG KWON , SUNG MIN BAE , SUNG HEE HONG , BYUNG SUN LEE , DEA SEONG IM , JEA MIN LEE
IPC: A61K20060101
Abstract: 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.