KRAUSE HANS-JUERGEN,FRAUNHOFER WOLFGANG,BARTL ANNIKA,KALETA KATHARINA,TSCHOEPE MARKUS
申请号:
NZ62258308
公开号:
NZ622583A
申请日:
2008.11.28
申请国别(地区):
NZ
年份:
2015
代理人:
摘要:
An aqueous pharmaceutical formulation consisting essentially of: (a) an anti-tumor necrosis factor alpha antibody such as adalimumab comprising a light chain variable region (LCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO:3, a CDR2 domain comprising the amino acid sequence of SEQ ID NO:5, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO:7, and a heavy chain variable region (HCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO:4, a CDR2 domain comprising the amino acid sequence of SEQ ID NO:6, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO:8, wherein the concentration of the antibody is 50 to 200 mg/ml; and (b) water. The disclosed formulations are substantially free of tonicity modifiers and buffers and are obtained by diafiltration.