원문정보
초록
영어
Analytical method development is one of the key factors for the successful development of biopharmaceutical manufacturing processes. Insulin-like growth factor-Ⅰ(IGF-Ⅰ), a 70 amino acids polypeptide hormone with three disulfide bonds has several important biological effects on cell cycle progression, cell proliferation, cell death and cell differentiation. Due to the
mismatch of intra- and intermolecular disulfide bridges renatured IGF-I has several product-related impurities and reverse-phase high performance liquid chromatography (RP-HPLC) is used as a analytical tool for the measurement of this variants. RP-HPLC method for the authentic IGF-I has been intensively studied but there are few reports on the RP-HPLC method for
the fusion IGF-I product. In this study new quantitative RP-HPLC method was developed for the ubiquitin fusion IGF-I to characterize and monitor the refolding process. The development procedures and the application of this method will be addressed in the presentation.