title: Method development and qualification of capillary zone electrophoresis for investigation of therapeutic monoclonal antibody quality.
abstract: Capillary electrophoresis techniques are widely used in the analytical biotechnology. Different electrophoretic techniques are very adequate tools to monitor size-and charge heterogenities of protein drugs. Method descriptions and development studies of capillary zone electrophoresis (CZE) have been described in literature. Most of them are performed based on the classical one-factor-at-time (OFAT) approach. In this study a very simple method development approach is described for capillary zone electrophoresis: a "two-phase-four-step" approach is introduced which allows a rapid, iterative method development process and can be a good platform for CZE method. In every step the current analytical target profile and an appropriate control strategy were established to monitor the current stage of development. A very good platform was established to investigate intact and digested protein samples. Commercially available monoclonal antibody was chosen as model protein for the method development study. The CZE method was qualificated after the development process and the results were presented. The analytical system stability was represented by the calculated RSD% value of area percentage and migration time of the selected peaks (<0.8% and <5%) during the intermediate precision investigation.
authors.affiliation: Chemical Works of Gedeon Richter Plc, 1103 Budapest, Gyömrői út 19-21, Hungary, Hungary. Electronic address: suba_d@yahoo.com.
authors.forename: Dávid
authors.initials: D
authors.lastname: Suba
authors.affiliation: Chemical Works of Gedeon Richter Plc, 1103 Budapest, Gyömrői út 19-21, Hungary, Hungary.
authors.forename: Zoltán
authors.initials: Z
authors.lastname: Urbányi
authors.affiliation: Budapest University of Technology and Economics, 1111 Budapest, Műegyetem rakpart 3, Hungary.
authors.forename: András
authors.initials: A
authors.lastname: Salgó
mesh_terms: D000911:Antibodies, Monoclonal / Q000032:analysis*; D019075:Electrophoresis, Capillary / Q000379:methods*; D006863:Hydrogen-Ion Concentration; D057230:Limit of Detection; D009994:Osmolar Concentration; D010084:Oxidation-Reduction
chemical_list: D000911:Antibodies, Monoclonal
keywords: Biotechnology; Capillary zone electrophoresis; Charge variants; Method development; Therapeutic monoclonal antibody