[Development of HPLC analysis methods for therapeutic monoclonal antibodies].
Therapeutic monoclonal antibody (mAb) preparations are produced from cultured cells; therefore, detailed and multidimensional analyses of their heterogeneities are required. We analyzed five commercially available mAb preparations by high-temperature reversed-phase LC using a wide-pore core-shell column for pluralistic quality assessment. At a highly elevated column temperature, isopropanol with high eluotropic strength coefficients and a wide-pore core-shell type octyl column showed good peak resolution of the investigated mAbs and their related constituents. We used this method to estimate the residual rate of intact mAbs after a heat aggregation treatment and conducted fragmentation analysis by analyzing their pepsin digests. Each peak component was identified by matrix-assisted laser desorption ionization-time of flight mass spectrometry. All results were compared with those of reversed-phase and size exclusion analyses.
School of Pharmaceutical Sciences, University of Shizuoka.
Kenichiro
K
Todoroki
D000911:Antibodies, Monoclonal / Q000032:analysis* / Q000627:therapeutic use; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D056148:Chromatography, Reverse-Phase; D066329:Protein Aggregates
D000911:Antibodies, Monoclonal; D066329:Protein Aggregates