Journal
BIOTECHNOLOGY AND BIOENGINEERING
Volume 118, Issue 9, Pages 3302-3312Publisher
WILEY
DOI: 10.1002/bit.27688
Keywords
biopharmaceutical; manufacturing; innovation; technology; factory of the future; continuous bioprocess; process intensification
Categories
Funding
- U.S. Department of Commerce [70NANB17H002, 70NANB20H037]
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The ambitious 10-year collaborative program aims to invent, design, demonstrate, and support integrated biopharmaceutical manufacturing technology to transform the industry, with goals including improved control, robustness, and security of supply, reduced capital and operating costs, flexibility in product supply, and faster development and supply chain velocity.
An ambitious 10-year collaborative program is described to invent, design, demonstrate, and support commercialization of integrated biopharmaceutical manufacturing technology intended to transform the industry. Our goal is to 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, and faster product development and supply chain velocity, with sustainable raw materials, components, 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 capacity 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.
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