HANMI SCIENCE CO. LTD.;SE CHANG KWON;SUNG MIN BAE;SUNG HEE HONG;BYUNG SUN LEE;DEA SEONG IM;JEA MIN LEE
发明人:
SE CHANG KWON,SUNG MIN BAE,SUNG HEE HONG,BYUNG SUN LEE,DEA SEONG IM,JEA MIN LEE
申请号：
IL22422513
公开号：
IL224225A
申请日:
2013.01.14
申请国别(地区):
IL
年份:
2018
代理人:
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&tilde；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.
