Principal Scientist Johnson & Johnson Innovative Medicine Spring House, Pennsylvania
Antibody drug conjugates (ADCs) present unique bioanalytical challenges due to their structural complexity and susceptibility to instability in biological matrices. A systematic approach is required to accurately evaluate payload and ADC stability while ensuring reliable data interpretation. This presentation outlines a practical workflow beginning with payload stability assessment across different anticoagulants, followed by evaluation of ADC stability under relevant handling conditions. Key considerations such as matrix selection, temperature, and species-dependent behavior will be discussed, highlighting how these factors influence observed payload levels and can complicate interpretation of stability data. In addition, analytical challenges associated with highly hydrophobic payloads, including solubility limitations, low LLOQ requirements, and carryover, will be presented along with practical mitigation strategies. The session will emphasize the importance of considering both biological and analytical contributions to observed results. Overall, this talk provides a pragmatic framework to improve confidence in ADC stability assessment and bioanalytical decision-making.
Learning Objectives:
Upon completion, participants will be able to describe a practical workflow for evaluating payload and ADC stability in biological matrix.
Upon completion, participants will be able to understand key factors influencing stability, including anticoagulant selection, sample handling, and species differences.
Upon completion, participants will be able to apply strategies to minimize instability and improve consistency in ADC bioanalytical studies, enhancing confidence in stability data for decision-making.
