DESIGN OF EXPERIMENTS (DOE) FOR DEVELOPMENT OF HIGH THROUGHPUT, FOR ASSESSMENT OF PRODUCT QUALITY

Presented by Jeremy Springall PhD, Scientist II, Analytical Sciences, R&D Biopharmaceutical Development, AstraZeneca Being able to generate accurate and precise analytical data to provide information on product quality in a timely manner is a great challenge facing analytical groups. By adopting a Design of Experiments (DoE) approach, we can overcome many hurdles facing the implementation and adoption of these high-throughput chromatography methods with the data generated being of comparable quality to that from longer lot release methods.