This is an ambitious 10-year collaborative program 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.
For more details, please refer to Erickson, J, Baker, J, Barrett, S, et al. (2021). End-to-end collaboration to transform biopharmaceutical development and manufacturing. Biotechnology Bioengineering. 118, 3302– 3312. https://doi.org/10.1002/bit.27688
Click here for a more detailed overview of the Process Intensification Program.
Login to the NIIMBL member portal to access more, including:
Not yet a member? Learn more about which level of NIIMBL membership is right for you and your organization.
NIIMBL
Amgen Inc.
AstraZeneca
Bristol-Myers Squibb
CSL Behring, LLC
Cytiva
Eli Lilly and Company
Emerson Automation Solutions
Federal Stakeholder: National Institute of Standards and Technology
Federal Stakeholder: National Science Foundation
Genentech, Inc.
GlaxoSmithKline, LLC
Janssen Research & Development, LLC
Just - Evotec Biologics
Merck Sharp & Dohme LLC
MilliporeSigma/EMD Serono
Pfizer, Inc.
Sanofi
Sartorius Stedim
Takeda Pharmaceuticals