Title: Developability Assessment of Therapeutic Proteins – A Toolbox for Tackling Increasing Complexity
Presenter: Thorsten Lorenz, Team Head Developability Assessment Biologics, Novartis
Early lead selection of biotherapeutics during preclinical development requires careful characterization of a variety of molecule properties to reduce the risk for encountering unexpected obstacles during technical development. The diversity and increasing complexity of new protein formats requires a change from former platform approaches often applied for antibodies, to project specific strategies. The developability assessment concept applied at Novartis combines information addressing various technical areas, such as expression, aggregation propensity, process fit, stability, physicochemical properties, etc. This integrated concept prior to lead selection provides a thorough, yet resource efficient approach to select suitable candidates.