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Trends Biotechnol. 2019 Mar;37(3):253-267. doi: 10.1016/j.tibtech.2018.08.008. Epub 2018 Sep 18.

The Current Scientific and Regulatory Landscape in Advancing Integrated Continuous Biopharmaceutical Manufacturing.

Author information

1
Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Silver Spring, MD 20993, USA; These authors have contributed equally to this article.
2
Department of Chemical Engineering, University of Massachusetts Lowell, Lowell, MA 01850, USA; These authors have contributed equally to this article. Electronic address: https://twitter.com/UMLEngineering.
3
Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Silver Spring, MD 20993, USA.
4
Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Silver Spring, MD 20993, USA. Electronic address: kurt.brorson@fda.hhs.gov.
5
Department of Chemical Engineering, University of Massachusetts Lowell, Lowell, MA 01850, USA; https://seongkyu-yoon.wiki.uml.edu. Electronic address: seongkyu_yoon@uml.edu.

Abstract

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. On the upstream side of biotechnology manufacturing, continuous perfusion cell cultures are fairly well established. However, truly integrated continuous biomanufacturing requires the uninterrupted connection of continuous unit operations (upstream and downstream) with no isolated intermediate or hold steps occurring between them. This work examines the current scientific and regulatory landscape surrounding the implementation of integrated continuous biomanufacturing.

KEYWORDS:

continuous bioprocessing; disposable; process analytical technology; quality by design; regulatory

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