END TO END COLLABORATION TO TRANSFORM BIOPHARMACEUTICAL DEVELOPMENT & MANUFACTURING

Published

January 22, 2021

Author(s)

John Erickson, Jeffrey Baker, Shawn Barrett, Ciaran Brady, Mark Brower, Ruben Carbonell, Tim Charlebois, Jon Coffman, Lisa Connell-Crowley, Michael Coolbaugh, Eric Fallon, Eric Garr, Christopher Gillespie, Roger Hart, Allison Haug, Gregg Nyberg, Michael Phillips, David Pollard, Maen Qadan, Irina Ramos, Kelley Rogers, Gene Schaefer, Jason Walther, Kelvin Lee

Abstract

An ambitious ten-year collaborative program is described to invent, design, demonstrate and support commercialization of integrated biopharmaceutical manufacturing technology that will transform the industry. This capability will enable improved control, robustness and security of supply, dramatically reduced capital and operating cost, flexibility to supply an extremely diverse and changing portfolio of products in the face of uncertainty and changing demand, faster product development and supply chain velocity, and sustainable raw materials, component and energy use. The program is organized into workstreams focused on end-to-end control strategy, equipment flexibility, next generation technology, sustainability, and a physical test bed to evaluate and demonstrate the technologies that are developed. The elements of the program are synergistic. For example, process intensification results in cost reduction as well as increased sustainability. Improved robustness leads to less inventory, which improves costs and supply chain velocity. Flexibility allows more products to be consolidated into fewer factories, reduces the need for new facilities, simplifies the acquisition of additional capcacity if needed, and reduces changeover time, which improves cost and velocity. The program incorporates both drug substance and drug product manufacturing, but this paper will focus on the drug substance elements of the program.

Citation

Biotechnology and Bioengineering

Pub Type

Journals

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DOI Link

Keywords

biopharmaceutical, manufacturing, innovation, technology, factory of the future, continuous bioprocess

Citation

Erickson, J. , Baker, J. , Barrett, S. , Brady, C. , Brower, M. , Carbonell, R. , Charlebois, T. , Coffman, J. , Connell-Crowley, L. , Coolbaugh, M. , Fallon, E. , Garr, E. , Gillespie, C. , Hart, R. , Haug, A. , Nyberg, G. , Phillips, M. , Pollard, D. , Qadan, M. , Ramos, I. , Rogers, K. , Schaefer, G. , Walther, J. and Lee, K. (2021), END TO END COLLABORATION TO TRANSFORM BIOPHARMACEUTICAL DEVELOPMENT & MANUFACTURING, Biotechnology and Bioengineering, [online], https://doi.org/10.1002/bit.27688 (Accessed October 2, 2025)