(67a) Biomanufacturing Science and Technology Consortium to Advance U.S. Manufacturing of Biopharmaceuticals

Biomanufacturing has become an emerging industry of strategic importance worldwide and is one of the key technology areas identified by the Advanced Manufacturing Partnership (AMP) as an appropriate target for public-private investment to support advances in manufacturing and U.S. competitiveness. The development of advanced biomanufacturing technologies will foster and support the fast growing biomanufacturing industry and for establishing sustained leadership of the US in the area (PCAST, 2012) (AMP 2, 2014).

The Biomanufacturing Science and Technology Consortium (BSTC) is hereby proposed, which will be led by academic and industry leaders across the nation. The proposed consortium is founded on the operational experiences of the Biopharmaceutical Process and Quality Consortium (BPQC) at University of Massachusetts Lowell (MA), which has been building collaborative efforts in advancing research and practice outcomes in the biopharmaceutical industry for four years. The proposed consortium represents a comprehensive team of actively participating stakeholders covering the entire spectrum of the industryâ??s value chain to identify challenges that the biomanufacturing industry is currently facing and to develop a dynamic roadmap to accelerate solutions. The consortium will be comprised of biomanufacturers including small and medium size businesses, research universities and colleges, government institutes and non-profits focusing on achieving the sustained U.S. leadership in biomanufacturing. The consortium will encompass multiple geological locations of strategic importance and disciplinary expertise areas, e.g., bio-engineering, regulatory and measurement sciences, education and workforce development. (BPQC, 2012).

The consortiumâ??s roadmapping exercise will take place at several strategic locations mainly through focused workshops. Each regional workshop will have an open brainstorming session to identify challenges and to encourage innovative ideas. The last concluding workshop will bring an active group of stakeholders and subject matter experts to synthesize and prioritize the outcomes from the multiple national and regional workshops. This consortium will also attempt to leverage the concept of crowdsourcing to inform additional ideas for solutions to key questions and to identify research projects. The proposed planning efforts will lead to a clear roadmap for a next generation biomanufacturing paradigm, reliable industry standard systems, and substantive knowledge spanning the industry challenges, as well as a list of potential pre-competitive projects covering the entire spectrum of topics toward the identified new paradigm. Through the roadmapping effort, this proposed consortium aims to lay the foundation for a sustained partnership among the members that will foster the U.S. competitiveness in the global market.

The consortium seeks to make all-encompassing plans to promote the development of advanced biomanufacturing science and technology, and also actively looks for the upgrade and transformation of existing biomanufacturing, as well as sharing resources and promoting innovations. Upon successful completion of this proposed planning effort, the consortium aims to conduct the following tasks:

• Prototyping a system of innovation for advanced biomanufacturing
• Developing breakthroughs in a number of key technologies
• Establishing technological standards and sustained global leadership of the U.S. biomanufacturing industry
• Building a robust and integrated supply chain network of an advanced biomanufacturing