(202e) Enabling Accelerated Downstream Process Development for Diverse Protein Therapeutic

At AbbVie we strive to continue growing our biologics pipeline to address unmet medical needs. Compared to the last decade there is significant increase in the quantity and molecular diversity of the candidates that come into CMC development; many are under accelerated timeline in order to bring these innovative therapies to patients as quickly as possible. The fast program speed and greater molecular complexity present significant challenges for process development team and manufacturing. To address these challenges we have established and deployed a comprehensive set of development strategies, which will be highlighted in this talk. Among these, the in-silico process development approach can potentially enable more efficient process development while enhancing process understanding and knowledge. Case studies on applying mechanistic and CFD modeling to optimize, characterize and/or validate downstream unit operations will be illustrated.