Challenges and Advances in Downstream Purification of Biopharmaceuticals
Ruben G. Carbonell
Biomanufacturing Training and Education Center (BTEC) and Department of Chemical and Biomolecular Engineering, NC State University
Monday October 16th
11:00 am
room TA05
Abstract
The biopharmaceutical industry is facing tremendous challenges with the demand 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 aided by government financial incentives. In addition, regulatory constraints require enhanced potency, efficacy and safety at the same time that there is a need for rapid approval and deployment of life-saving vaccines and other medications, such as the emerging DNA/RNA-based and stem cell-based therapeutic platforms.
As a result, there is a great deal of interest in the development of novel downstream processes that will speed up production, reduce the number of process steps, the process footprint, buffer and energy use, regulatory burden, and at the same time are simple and flexible enough to be applied to a large segment of product platforms and be readily transferrable to different sites. To this end, single use devices, low cost affinity media, membrane chromatography, process intensification, in-line validation and many other approaches are currently being evaluated. 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 the use inexpensive, high-throughput, high binding-capacity non-woven membranes and resins 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.