Progress in study on difficulties of quality control of PEGylated UOX / 中国药学杂志

ABSTRACT

PEGylated UOX is a kind of modified pharmaceuticals designed by coupling PEG with UOX to increase in vivo circulation half-life and reduce immunogenicity. UOX is modified by PEG at random multiple sites, which results in more complicated physical and chemical characteristics and in vivo and in vitro activities than UOX. At present, there is no standardized quality analysis method for such drugs. Through collecting and summarizing references about the quality control method of PEG-modified drugs in recent years, this article summarizes the analysis methods for three difficulties of the quality control of UOX namely the average extent of modification, consistency of modification and PEGylation sites so as to provide technical guidance for enterprises to develop the drug.