Abstract:
OBJECTIVE To establish therapeutic monoclonal antibodies(mAbs) drugs' physical and chemical platform based on USP general principle <129>.
METHODS This platform was consisted of SEC-HPLC, CE-SDS, CE and HPLC for the analysis of
N-glycosylation, and ion chromatography for the evaluation of sialic acid. To improve the platform, a WCID-CIEF method was established as a charge heterogeneity analysis method, and a UPLC method, which was more sensitive and stable, was investigated for the determination of sialic acid. These methods could reveal high molecular weight and low molecular weight variants,
N-glycosylation, sialic acid content and charge variants of mAb drugs.
RESULTS These methods were verified through system suitability tests and applied in four mAbs, including Adalimumab, Bevacizumab, Tocilizumab, Nimotuzumab. The results showed that these platform methods were suitable for the physical and chemical properties analysis of mAb drugs.
CONCLUSION This platform may provide reference methods in mAb drugs' quality control for industry and regulators.