DILUZIO WILLOW,VARGA CSANAD M.,PALANIAPPAN VAITHIANATHAN,BROWN JASON,FOX IRVING H.,SCHOLZ CATHERINE,TRUONG NOBEL T.
申请号：
NZ61783312
公开号：
NZ617833A
申请日:
2012.05.02
申请国别(地区):
NZ
年份:
2016
代理人:
摘要：
Disclosed is a stable pharmaceutical formulation comprising a mixture of a non-reducing sugar, an anti-&alpha4&bgr7 antibody and one free amino acid, wherein the formulation is lyophilised, and the molar ratio of non-reducing sugar to anti-&alpha4&bgr7 antibody (mole:mole) is 700:1, wherein the free amino acid to antibody molar ratio is at least 250:1, and wherein the antibody comprises a heavy chain variable region comprising a complementarity determining region (CDR1) as set forth in SEQ ID NO: 8, a CDR2 as set forth in SEQ ID NO: 9, and a CDR3 as set forth in SEQ ID NO: 10, and comprises a light chain variable region comprising a CDR1 as set forth in SEQ ID NO: 11, a CDR2 as set forth in SEQ ID NO: 12, and a CDR3 as set forth in SEQ ID NO: 13, wherein the sequences are as disclosed in the complete specification. Also disclosed is a stable pharmaceutical formulation comprising 45% to 55% sucrose (w/w), an anti-&alpha4&bgr7 antibody, histidine, arginine, and polysorbate 80, wherein the formulation is lyophilised, wherein the molar ratio of total amino acid to antibody is at least 400:1, and wherein the antibody comprises a light chain variable region comprising amino acids 20-131 of SEQ ID NO: 4 and a heavy chain variable region comprising amino acids 20 to 140 of SEQ ID NO: 2, wherein the sequences are as disclosed in the complete specification.
