HAVENITH, CATHARINA EMANUELE GERARDA,VINK, TOM,VAN BERKEL, PATRICK,PARREN, PAUL
申请号：
NZ58968706
公开号：
NZ589687A
申请日:
2006.07.21
申请国别(地区):
NZ
年份:
2012
代理人:
摘要：
Disclosed is a method of characterizing an antibody, which method is suitable as a potency assay for batch release of a pharmaceutical composition comprising an antibody, specifically for use when applying for marketing authorization for said pharmaceutical composition. The assay provided is a method for determining the potency of a drug product comprising an FcR binding peptide, wherein at least one mechanism of action of the FcR binding peptide of the drug product is mediated through the binding of the FcR binding peptide of the drug product to a Fc receptor, wherein said method comprises determining the binding of the FcR binding peptide of the drug product to an Fc receptor.
