title: Quality assurance of monoclonal antibody pharmaceuticals based on their charge variants using microchip isoelectric focusing method.
abstract: Monoclonal antibody (mAb) pharmaceuticals are much more complex than small-molecule drugs. Such complex characteristics raise challenging questions for regulatory evaluation. Although heterogeneity in mAbs based on their charge variants has been mainly evaluated using gel-based isoelectric focusing (IEF) method, recent development in capillary electrophoresis and microchip electrophoresis has made it possible to assure their heterogeneities in more easy and rapid manner. In the present paper, we customized the imaged microchip isoelectric focusing (mIEF) for the analysis of mAbs, and compared the customized version with the conventional capillary isoelectric focusing (cIEF) method, and found that mIEF has much higher performance in operations, and its resolving powers are comparable with those obtained by cIEF.
authors: Faculty of Pharmacy, Kinki University, Kowakae 3-4-1, Higashi, Osaka 577-8502, Japan.
authors: Mitsuhiro
authors: M
authors: Kinoshita
authors: Yuki
authors: Y
authors: Nakatsuji
authors: Shigeo
authors: S
authors: Suzuki
authors: Takao
authors: T
authors: Hayakawa
authors: Kazuaki
authors: K
authors: Kakehi
mesh_terms: D000911:Antibodies, Monoclonal / Q000737:chemistry*; D046209:Electrophoresis, Microchip / Q000379:methods*; D007525:Isoelectric Focusing / Q000379:methods*; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D011786:Quality Control
chemical_list: D000911:Antibodies, Monoclonal; D004364:Pharmaceutical Preparations
keywords: Antibody; Charge variant; Isoelectric focusing; Microchip