CBE Seminar: Ruben G. Carbonell

“Downstream Purification of Biopharmaceuticals: Challenges and Opportunities”

The biopharmaceutical industry is facing demands for cost reductions in medications in developed countries with aging populations, as well as in developing countries with growing middle classes.  The advent of biosimilars has led to increased competition from other countries.  In addition, regulatory constraints require enhanced potency, efficacy and safety while there is a need for rapid approval and deployment of life-saving vaccines, and novel gene-based and stem cell-based therapeutics.

There is a great deal of interest in the development of novel downstream processes to accelerate production, reduce process steps, process footprint, buffer and energy use, and regulatory burdens.  Single use devices, low cost affinity media, membrane chromatography, process intensification, in-line validation and other approaches are being explored.  Our group has pioneered the use of synthetic peptide libraries for the identification of low cost ligands with high affinity and selectivity for a wide variety of protein targets. In addition, we are pursuing inexpensive, high-throughput, high binding-capacity non-woven membranes as solid supports for product or contaminant capture. These developments might enable “truly continuous” purification strategies based on flow-through separation steps relying completely on disposable membranes.

Seminar Flyer_Ruben G. Carbonell