GARIDEL PATRICK,HENDERSON ISAAC CRAIG,KLEIN PAMELA
申请号：
NZ62360612
公开号：
NZ623606A
申请日:
2012.10.25
申请国别(地区):
NZ
年份:
2015
代理人:
摘要：
Disclosed is a lyophilised formulation of an antibody, comprising (a) a humanized version of antibody 2A4 (ATCC Accession Number PTA-9662) or antigen binding fragment thereof, or antibody 7D8 (ATCC Accession Number PTA-9468) or antigen binding fragment thereof； (b) L-histidine； (c) L-histidine HCl monohydrate； (d) trehalose； and (e) polysorbate 20, in such amounts, which upon reconstruction yield an aqueous solution wherein: (i) the antibody is present at a concentration within the range from 5 mg/ml to 15 mg/ml； (ii) a histidine buffer is present at a concentration within the range from 20 mM to 30 mM； 15 (iii) the trehalose is present at a concentration within the range from 210 mM to 250 mM； (iv) the polysorbate 20 is present at a concentration within the range from 0.005% to 0.05% by weight； and wherein the aqueous solution has a pH within the range from 6 to 7.
