The Current Scientific and Regulatory Landscape in Advancing Integrated Continuous Biopharma Manufacturing



There is a trend across the pharmaceutical sector toward process intensification and continuous manufacturing to produce small-molecule drugs or biotechnology products. For biotechnology products, advancing the manufacturing technology behind upstream and downstream processes has the potential to reduce product shortages and variability, allow for production flexibility, simplify scale-up procedures, improve product quality, reduce facility footprints, increase productivity, and reduce production costs. This work examines the current scientific and regulatory landscape surrounding the implementation of integrated continuous biomanufacturing.

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