Recent advances in ADC development have led to increasingdiversity in antibody, linker and payload design. Successful drug product(DP)development for different ADCs in a CDMO environment requires a clear understandingof how key DP factors—includingformulation, stability, manufacturing, dosage form, and route of administration— interact with one another and are influenced by ADCmolecular design.
This presentation examines common challenges in ADC DPdevelopment and production from both theoretical and practical perspectives.Case studies will be shared to demonstrate practical solutions enabled by ourplatform technologies.
Key Learning Objectives
· Common challenges in ADC drug productdevelopment
· Strategies to mitigate light- andoxidation-induced degradation of ADCs
· Optimization of lyophilized DP formulations forADCs
· Customized in-use evaluations to supportclinical administration
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