Application of DOE Design of Experiments to Antibody Drug Conjugates ADC Process Development

Application of DOE (Design of Experiments) to Antibody Drug Conjugates (ADC) Process Development Discover how Design of Experiments (DOE) can revolutionize the early phase process development of Antibody Drug Conjugates (ADCs). This insightful webinar is a co-presentation featuring Xavier Despinoy from Piramal Pharma Solutions and Eric Johansson from Sartorius Data Analytics. The experts detail a conjugation project, explaining Piramal's 15+ years of ADC bioconjugation expertise, combined with Sartorius’s extensive knowledge in DOE and Quality by Design (QbD). They focus on a four-step active conjugation process and the strategic selection of critical parameters, including protein concentration, pH, temperature, and reaction time. Learn how DOE allows for the systematic assessment of multiple factors simultaneously, facilitating the efficient definition of the process Design Space. The presenters demonstrate the use of Umetrics MODDE software to analyze the results, specifically focusing on optimizing the critical quality attribute of Drug-to-Antibody Ratio (DAR). The discussion highlights practical challenges, from achieving robust set points to managing scaling variability.