title: Quality Control of Therapeutic Monoclonal Antibodies at the Hospital After Their Compounding and Before Their Administration to Patients.
abstract: Monoclonal antibodies (mAbs) are widely used in cancer therapy and recently many new mAbs have gained EMA and FDA approvals for oncology indications. Here we describe a highly reproducible CZE method, relying on a cationic coating allowing separation and identification of a complex mixture of four compounded mAbs widely used in cancer therapy (cetuximab, rituximab, bevacizumab, and trastuzumab).
authors.affiliation: Institut Galien Paris-Sud, UMR 8612, Proteins and Nanotechnology in Analytical Science, CNRS, Univ Paris-Sud, Univ Paris-Saclay, 5 rue Jean-Baptiste Clément, 92296, Châtenay-Malabry, France.|Hôpital Européen Georges Pompidou, Paris, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Jaccoulet
authors.affiliation: Institut Galien Paris-Sud, UMR 8612, Proteins and Nanotechnology in Analytical Science, CNRS, Univ Paris-Sud, Univ Paris-Saclay, 5 rue Jean-Baptiste Clément, 92296, Châtenay-Malabry, France. claire.smadja@u-psud.fr.
authors.forename: Claire
authors.initials: C
authors.lastname: Smadja
authors.affiliation: Institut Galien Paris-Sud, UMR 8612, Proteins and Nanotechnology in Analytical Science (PNAS), CNRS, Univ. Paris-Sud, Université Paris-Saclay, Châtenay-Malabry, France.
authors.forename: Myriam
authors.initials: M
authors.lastname: Taverna
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000302:isolation & purification*; D000074322:Antineoplastic Agents, Immunological / Q000008:administration & dosage / Q000302:isolation & purification*; D000068258:Bevacizumab / Q000008:administration & dosage / Q000302:isolation & purification; D000068818:Cetuximab / Q000008:administration & dosage / Q000302:isolation & purification; D004339:Drug Compounding; D019075:Electrophoresis, Capillary / Q000379:methods*; D006801:Humans; D011786:Quality Control; D000069283:Rituximab / Q000008:administration & dosage / Q000302:isolation & purification; D000068878:Trastuzumab / Q000008:administration & dosage / Q000302:isolation & purification
chemical_list: D000911:Antibodies, Monoclonal; D000074322:Antineoplastic Agents, Immunological; D000068258:Bevacizumab; D000069283:Rituximab; D000068878:Trastuzumab; D000068818:Cetuximab
keywords: Capillary electrophoresis; Cationic coating; Hospital; Monoclonal antibodies; Polybrene; Quality control; mAb identification