Be part of the only event dedicated to understanding and working through the analytical challenges faced by drug developers including drug-linker, drug substance, drug product and drug formulation
Regulatory expectations for ADCs have become narrower and narrower with previous nice-to-know information about your ADC becoming need-to-know, and extended characterization beginning to take place earlier and earlier. This has created a growing need for this community to unite to optimize physiochemical, potency and impurity assays to enhance ADC product understanding and quality to support these regulatory conversations.
Uniting 120+ ADC developers working in analytical development, CMC, technical operations, quality control and characterization including Daiichi Sankyo, Eli Lilly, ADC Therapeutics, Exelixis; this meeting combines a range of stakeholders from technical scientists through to more senior directors to network and share insightful insights with fellow peers.
5 Reasons You Cannot Miss Out On This Event
Understand regulatory considerations on control strategies for ADC products with the FDA
Analyze the importance of species separation challenges and explore how methods beyond reverse phase HPLC can aid in reducing drug product impurities with Mersana Therapeutics
Reduce process variation by navigating complexity of ADCs and overcome heterogeneity to ultimately find standardized approaches to quantify conjugation with Bristol Myers Squibb and Takeda Pharmaceuticals
Overcome the hurdle of cell line selection to gain a more accurate reflection of ADC’s MoA and carry out earlier CQA assessments with AstraZeneca
