윤성규 (University of Massachusetts Lowell) | 한빛사논문 > 한빛사

한빛사논문

조회1,271

University of Massachusetts Lowell

CV File 112 kb

Trends Biotechnol., Available online 18 September 2018 | https://doi.org/10.1016/j.tibtech.2018.08.008 The Current Scientific and Regulatory Landscape in Advancing Integrated Continuous Biopharmaceutical Manufacturing

Adam C. Fisher,^1,3 Mark-Henry Kamga,^2,3 Cyrus Agarabi,¹Kurt Brorson,^1,* Sau L. Lee,¹ and Seongkyu Yoon^2,4,*¹Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Silver Spring, MD 20993, USA ²Department of Chemical Engineering, University of Massachusetts Lowell, Lowell, MA 01850, USA
³These authors have contributed equally to this article
⁴https://seongkyu-yoon.wiki.uml.edu

^*Correspondence: Kurt Brorson, Seongkyu Yoon

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.

논문정보

형식Review Paper
게재일2018년 09월 (BRIC 등록일 2018-11-21)
연구진국외 연구진
분야

댓글 작성 로그인

CV 열람하기

연락처 보기