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Bioseparations - Quo Vadis?

Department of Chemical and Biomolecular Engineering
NC State University

Dr. Abhinav A. Shukla
Manufacturing Sciences and Technology
Bristol-Myers Squibb Co.
Syracuse NY

Bioseparations—the art and science of purifying biological macromolecules—has changed in radical ways since the first use of chromatographic separation processes over a century ago. In recent years, the explosion in numbers and in the market share of biopharmaceuticals have vastly expanded the range of application of bioseparation unit operations. However, a number of forces are re-shaping the biopharmaceutical arena. Some of these factors include: a significant increase in the number of biopharmaceutical products and drug candidates due to enhanced interest from both biotech and big pharma, the advent of monoclonal antibodies as a key product class requiring larger production scales and higher productivity, a heightened focus on drug safety at the FDA, the advent of personalized therapeutics and increasing competition—both from innovator companies and from the looming threat of biosimilars. This presentation shares a perspective on how these forces will shape the field of bioseparations.

To lay the stage for this discussion, particular emphasis will be paid to monoclonal antibody (mAb) downstream processing and how some of the separations challenges unique to this product class are being overcome. Some of the topics that will be discussed include: the creation of a platform approach for mAb processes, the solution of issues with product aggregation, precipitation, host cell protein impurity clearance, column regeneration and productivity optimization for Protein A chromatography. The presentation will also highlight some recent trends in process validation and the implementation of the Quality by Design (QbD) framework for biopharmaceutical manufacturing processes. Finally, the presentation will share a vision for how academic research can play a key role in helping this dynamic field evolve in the coming years.

Refreshments will be served from 11:40-12:00 noon in the Faculty Lounge.