HONG SUNG HEE,LEE BYUNG SUN,IM DAE SEONG,LEE JAE MIN,BAE SUNG MIN,KWON SE CHANG
申请号:
IN1093/DELNP/2013
公开号:
IN2013DN01093A
申请日:
2013.02.05
申请国别(地区):
IN
年份:
2014
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 5.0~6.0 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.