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Antibody formulation and therapeutic regimens
专利权人:
KIRIN-AMGEN INC.
发明人:
RUSSELL CHRISTOPHER BOYD,SALINGER DAVID H.,LIU DINGJIANG,ENDRES CHRISTOPHER J.,HUANG HOLLY ZHUOHONG,MARTIN DAVID ANDREW,BAUMGARTNER SCOTT WALTER
申请号:
NZ60112511
公开号:
NZ601125A
申请日:
2011.01.12
申请国别(地区):
NZ
年份:
2014
代理人:
摘要:
Disclosed is a pharmaceutical formulation, comprising an aqueous solution of a glutamic acid buffer and an antibody comprising a heavy chain CDR1 comprising SEQ ID NO: 5, a heavy chain CDR2 comprising SEQ ID NO: 7, a heavy chain CDR3 comprising SEQ ID NO: 8, a light chain CDR1 comprising SEQ ID NO: 9, a light chain CDR2 comprising SEQ ID NO: 10, and a light chain CDR3 comprising SEQ ID NO: 11, wherein the sequences are as defined in the complete specification, wherein said antibody specifically binds human IL-17 receptor A, and wherein: a) said formulation comprises a glutamic acid concentration of 10 ± 0.2 mM; b) said formulation comprises a pH of 4.5-5.2 ± 0.2; c) said formulation further comprises 3 ± 0.2% proline (w/v) and 0.01 ± 0.002% (w/v) polysorbate 20; d) said antibody is at a concentration of about 140 ± 5% mg/ml; and e) said formulation has a viscosity of 5 to 7 cP at 25 degrees C. Also disclosed is the use of said pharmaceutical formulation for the treatment of psoriasis, psoriatic arthritis, asthma, ankylosing spondylitis and multiple sclerosis.
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中国工程科技知识中心
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