ADLER MICHAEL,GRAUSCHOPF ULLA,MAHLER HANNS-CHRISTIAN,STAUCH OLIVER BORIS
申请号：
NZ60390010
公开号：
NZ603900A
申请日:
2010.07.28
申请国别(地区):
NZ
年份:
2014
代理人:
摘要：
603900 Disclosed is a highly concentrated, stable pharmaceutical liquid formulation of a pharmaceutically active anti-HER2 antibody for subcutaneous injection comprising: a. about 120 ± 18 mg/ml anti-HER2 antibody； b. about 1 to 50 mM ofa histidine buffer providing a pH of5.5 ± 0.6； c. about 1 to 500 mM of a stabilizer or a mixture of two or more stabilizers； and d. about 0.01 to 0.08 % of a nonionic surfactant； with the proviso that the formulation does not include a hyaluronidase enzyme at a concentration of >； 150 to 16,000 U/ml.
