Critical Quality Attribute Investigation and Analytical Method Establishment for Glyco-Site-Specific Anti-HER2 Bispecific ADC. (PubMed, Pharmaceuticals (Basel)) - Sep 27, 2026 - "Background/Objectives: Bispecific antibody-drug conjugates (bispecific ADCs) are among the most rapidly advancing antibody therapeutic modalities, with only one product (BL-B01D1) currently approved for marketing worldwide to date... We established quality control methods for the assessment of mispaired species, conjugation site, drug-to-antibody ratios (DARs), charge variants, residual free drugs, residual β1,4-galactosyltransferase I (GalT) enzyme, relative binding activity, and cell proliferation inhibition activity. An analytical method suite was developed for the bispecific ADC to comprehensively characterize and appropriately control its critical quality attributes, thereby guiding the research, development, and manufacturing process optimization of the ADC product and ensuring its safety, efficacy, and quality consistency."
Journal • HER-2
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Chuanfei Yu; Lan Wang; Lele Wang; Tao Tang; Weirong Cao; Xiaojuan Yu; Yalan Yang; Yan Li; Yangwei Fu; Yao Tang
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