2017 16(5):315–37.īuckwalter M, Dowell JA, Korth-Bradley J, Gorovits B, Mayer PR. Strategies and challenges for the next generation of antibody–drug conjugates. Quantitative analysis of maytansinoid (DM1) in human serum by on-line solid phase extraction coupled with liquid chromatography tandem mass spectrometry-Method validation and its application to clinical samples. Contribution of linker stability to the activities of anticancer immunoconjugates. KeywordsĪlley SC, Benjamin DR, Jeffrey SC, Okeley NM, Meyer DL, Sanderson RJ, et al. This chapter provides an introductory understanding of the structure and chemistry of ADC molecules and various bioanalytical strategies used for their pharmacokinetic and immunogenicity assessment. ADC bioanalysis thus necessitates an integrated bioanalytical approach including both ligand-binding assays and liquid chromatography coupled with mass spectrometry-based assays, conventionally used for large- and small-molecule bioanalysis, respectively. Because of their complex structure combining large- and small-molecule drug characteristics and their heterogeneous and dynamic nature, unique bioanalytical strategies are needed to identify, characterize, and quantify ADCs for their safety and efficacy assessments. The ADC molecule typically comprises of a cytotoxic small-molecule drug covalently bound to a monoclonal antibody via a linker. Antibody-drug conjugates (ADCs) are a rapidly evolving class of biotherapeutics mostly developed for the treatment of cancer.
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