Compared with significant advances in upstream production of recombinant proteins, downstream purification processes have undergone far less development over the past twenty or thirty years. Technologies are emerging for continuous-mode and/or multicolumn chromatography (MCC) operations, but commercial-scale biomanufacturing operations still rely on chromatography equipment and processes that closely resemble those used at the advent of monoclonal antibody (MAb) manufacturing. Thus, chromatography operations generally have not kept pace with upstream gains, resulting in manufacturing bottlenecks at purification stages. Compounding that concern is that chromatography workflows remain costly and resource intensive. Considering that large-scale MCC generally remains in development stages, drug makers still could benefit significantly from strategies for optimizing their existing commercial-scale purification approaches.

In this eBook, three BPI editorial advisors call out some of the pain points that remain in chromatography operations. Those obstacles include high costs for required media, buffers, and equipment, as well as less-considered difficulties with labor and facility requirements. The eBook contributors also explore operational and regulatory factors that have limited — and, in some cases, continue to hamper — innovation in chromatography workflows. Read the eBook to learn about considerations for mitigating biomanufacturing bottlenecks at purification stages.

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