Abstract

Symposium Sessions

Day 1, June 10（Mon.）　16:45-17:05　Room C (Conference Room 201)

Understanding the diverse product quality attributes of biopharmaceuticals is crucial for their efficacy, safety, and efficient manufacturing. Mass spectrometry is a vital tool in this process, particularly as the demand for analysis of complex molecules like antibody-drug conjugates (ADCs) increases. Representative applications include intact MS for drug-antibody ratio confirmation, multi-attribute method (MAM) for amino acid sequence confirmation and modification semi-quantification, and proteomics-like methods for host cell protein identification. Standardization of these methods is being considered by regulatory bodies globally. This presentation describes the application of mass spectrometry, including detailed characterization and plasma stability evaluation of ADCs manufactured by site-specific conjugation technology named AJICAP(R). The detailed peptide mapping revealed the site-specificity of Lys conjugation, and optimized sample preparation suppressed artifact modifications. The plasma stability study posed challenges to intact MS analysis of the ADCs due to the low concentration and plasma interference, and we will present our approaches including data processing such as time resolved deconvolution to overcome these issues.

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