(475a) Continuous Chromatography: Breaking the "Bottleneck" in Downstream Processing

Multi-column continuous chromatography has recently become an enabling technology that will “break the bottleneck” in downstream processing of bio-pharmaceuticals. This development is not only driven by the tremendous increases in expression levels in the upstream fermentations, especially for monoclonal antibodies, but also by the introduction of biosimilars/biobetters the market. Continuous chromatography has shown promises in reduction of manufacturing cost. However, up to today there has not been a reported case at the production scale. What are the remaining technical barriers when implementing the technology in the GMP environment? This presentation highlights how to overcome the major barriers when developing this technology platform.