Recombinant therapeutic monoclonal antibodies. Determination of product-related impurities according to USP 129 and Ch.P 3127

INTRODUCTION

The present method is used for the determination of product-related impurities in recombinant therapeutic monoclonal antibodies (Immunoglobulin G, IgG) according to United States Pharmacopoeia general chapter 129 (Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies, Capillary SDS electrophoresis) using CAPEL-205 capillary electrophoresis system. Alternatively, the determination of IgG impurities in accordance with Chinese Pharmacopoeia general chapter 3127 (Monoclonal antibodies – Determination of molecular size variants (CE-SDS)) can also be performed using CAPEL-205.