Biopharmaceuticals are the most rapidly developing part of the biotechnology industry, marked by monoclonal antibody drugs. Currently, 35 antibody drugs have been approved for marketing, used for cancer, autoimmune, macular degeneration, hematological diseases, and infection treatment. In every production process of biopharmaceuticals, the purification and analysis of products are crucial. In the quality control process of early antibodies, it is necessary to determine the potency, aggregates, and charge subtypes of the sample. The two main impurities in monoclonal antibody (MAb) products are charge subtype monoclonal antibodies and monoclonal antibody aggregates, which can produce different pharmacological effects from the main product and sometimes cause serious side effects, such as the formation of drug-resistant antibodies. Protein oligomers are produced during production, purification, or transportation processes (such as temperature and pH effects). This article discusses the simultaneous separation of monoclonal antibody aggregates and charge subtypes using an HPLC system (UltiMate 3000 titanium system).

Test condition instrument: UltiMate 3000 titanium system, including a dual ternary gradient pump with an online degassing unit; Ten way valve with biocompatibility; WPS-3000T (B) FC analytical type, automatic sampler with sample collection function; Ultraviolet detector (UV); Diode Array Detector (DAD). The system connection is shown in Figure 1.

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