This chapter provides guidance and procedures used for characterization of biotechnology-derived articles by capillary electrophoresis. This chapter is harmonized with the corresponding chapter in JP and EP. Other characterization tests, also harmonized, are shown in Biotechnology-Derived Articles—Amino Acid Analysis 〈1052〉, Biotechnology-Derived Articles—Isoelectric Focusing 〈1054〉, Biotechnology-Derived Articles—Peptide Mapping 〈1055〉, Biotechnology-Derived Articles—Polyacrylamide Gel Electrophoresis 〈1056〉, and Biotechnology-Derived Articles—Total Protein Assay 〈1057〉.