END TO END COLLABORATION TO TRANSFORM BIOPHARMACEUTICAL DEVELOPMENT & MANUFACTURING
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.
Biotechnology and Bioengineering
biopharmaceutical, manufacturing, innovation, technology, factory of the future, continuous bioprocess