ASHLEY REEDER1, BOB LENICH2, BRUCE KANE3, CHARLES HEISE4*, DONALD GIBBS5, GRAEME MOODY6, KRISTINA PLEITT7, LARA FERNANDEZ-CEREZO8, MARK SCHOFIELD9, ANDREA JOHNSTON6
*Corresponding author
1. GSK, King of Prussia, USA
2. Emerson, Austin, USA
3. Rockwell Automation, Wisconsin, USA
4. FUJIFILM Diosynth Biotechnologies, Cleveland, United Kingdom
5. Asahi Kasai Bioprocess, Chelmsford, USA
6. BioPhorum Ltd, The Gridiron Building, One Pancras Square, London, United Kingdom
7. Thermo Fisher Scientific, St Louis, USA
8. Merck & Co, Rahway, USA
9. Cytiva, Westborough , USA

Abstract

Continuous processing has been implemented for the intensification of manufacturing in many industries, including small molecule drug production. However, adoption of continuous processing for biopharmaceutical manufacturing has been occurring at a relative slow rate. Biophorum has been active in understanding the biomanufacturing landscape to help promote and establish implementation of continuous manufacturing technologies through a cross-industry team of end-users, suppliers and integrators. This team has identified barriers, provided innovative solutions, and collaborated with industry stakeholders to develop a consensus approach in a number of areas such as optimizing buffer management bottlenecks, defining process control strategies, and developing templates for critical process parameter evaluation. Through these activities, significant progress has been made in enabling faster implementation of continuous processes in a GMP environment, reducing time-to-market, and lowering manufacturing costs. This article provides an overview of this cross industry team’s accomplishments and highlights the impact of their efforts in driving the adoption of continuous biomanufacturing across the pharmaceutical industry.