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Process Intensification PROGRAM

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.
Categories
Drug substance
Drug product
Assays
Equipment and Supplies
Process control
Data

Solution

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.

Updates, Related Publications, and Deliverables

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Participating Organizations

Amgen Inc.

Amgen Inc.

AstraZeneca

AstraZeneca

Bristol-Myers Squibb

Bristol-Myers Squibb

CSL Behring, LLC

CSL Behring, LLC

Cytiva

Cytiva

Eli Lilly and Company

Eli Lilly and Company

Emerson Automation Solutions

Emerson Automation Solutions

Federal Stakeholder:  National Institute of Standards and Technology

Federal Stakeholder: National Institute of Standards and Technology

Genentech

Genentech

GlaxoSmithKline, LLC

GlaxoSmithKline, LLC

Janssen Research & Development, LLC

Janssen Research & Development, LLC

Just - Evotec Biologics

Just - Evotec Biologics

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

MilliporeSigma/EMD Serono

MilliporeSigma/EMD Serono

NIIMBL

NIIMBL

Pfizer, Inc.

Pfizer, Inc.

Sanofi

Sanofi

Sartorius Stedim

Sartorius Stedim

Takeda Pharmaceuticals

Takeda Pharmaceuticals

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