Emerging Therapy Development: Raising the Probability of Success

Maurice Phelan, site head of Cambridge US cell line and testing solutions at Sartorius Stedim Biotech, joined the BPI Theater at BIO on Tuesday, 4 June 2019, to explain how a strong data analytics platform combined with solid product characterization can make all the different in emerging therapy development. An explosion of data has come from the advent of process sensors and process characterization study. With these data, Phelan suggests, sponsors can use platforms such as the Sartorius SICAM system to evaluate a product’s critical quality attributes (CQAs), and doing that will determine the right cellular clone to study and ultimately mass-produce.