CMaT - National Cell Manufacturing Consortium Roadmap
Over 25 companies and 15 academic institutions collaborated together with government agencies to produce a national roadmap on cell therapy manufacturing. The National Cell Manufacturing Consortium (NCMC) is the first U.S. based national consortium focused on developing, maturing, and implementing technologies that can enable large-scale, cost-effective manufacturing of therapeutic cells. NCMC is established through the Advanced Manufacturing Technologies (AMTech) grant from the National Institute of Standards and Technologies (NIST).
Details
This roadmap was developed through a public-private partnership under the direction of Greg Dane, Director of the Industry Fellows Program at Georgia Research Alliance; Krishnendu Roy, Robert A. Milton Chair of Biomedical Engineering at Georgia Institute of Technology; and the National Cell Manufacturing Consortium Executive Committee with direct input from industry, academia, clinical facilities, private foundations, and government agencies. Nexight Group supported the overall roadmapping process and prepared this roadmap; Sarah Lichtner, Ross Brindle, and Lindsay Pack are the primary contributors. The cell manufacturing industry experts who made vital contributions through workshop participation, working group support, and roadmap reviews are identified in Appendix B of this report.
Who Should Read this Roadmap? This roadmap will be of use to a variety of individuals within and beyond the cell manufacturing community. It is not written solely for pharmaceutical or biotechnology companies, but rather for a range of stakeholders within industry, academia, and government who are critical to advancing this industry. Achieving large-scale, reproducible production of high-quality therapeutic cells at low cost will require a convergence science approach that brings together clinicians, cell biologists, and immunologists with a wide variety of engineers and scientists—not only bioengineers and chemical engineers who have been classically involved in biomanufacturing, but also electrical and mechanical engineers, computer and data scientists, systems biologists, chemists, physicists, and manufacturing and industrial engineers. To realize large-scale cell manufacturing, industry and clinical Good Manufacturing Practice (GMP) centers must focus on the priority activities outlined in this roadmap to drive the development and implementation of advanced cell manufacturing technologies and techniques. Academic researchersmust support these efforts by conducting the R&D necessary to bring these life-changing tools and techniques to market. Sensors and automation, big data analytics and machine learning, process engineering and plant design, and systems integration and instrumentation must all be an integral part of the fundamental national strategy to achieve success in industrial-scale cell manufacturing. To inform the efforts of industry scientists and academic researchers, physicians, biologists, and clinical scientists must provide the supporting knowledge and design parameters necessary to realize the therapies and treatments that will allow them to improve the lives of millions of people.In the absence of regulatory buy-in, standardization, social buy-in, and insurance reimbursement, the promises of cell therapies and regenerative medicine will fail to reach their transformative potential. Government agencies, law makers, regulatory personnel, standards organizations, policy experts, the reimbursement industry, and private foundations must acknowledge the cell manufacturing industry’s areas of priority need, focusing resources in these areas and developing regulations and standards that can facilitate this industry’s accelerated growth.
Overview
Over the past few decades, cell-based medical technologies have helped treat many patients with cancer, blood disorders, vision disorders, and other ailments. In 2012 alone, these products treated more than 160,000 patients. Though this relatively new industry has been growing significantly—with annual U.S. revenue above $1 billion—its potential is still far from being fully realized.
New and emerging cell-based healthcare products, such as cell therapies, engineered tissues, medical devices, and drug discovery and testing platforms, could help manage and even cure many conditions and diseases that are intractable, chronic, and even terminal today, including cancer, heart failure, paralysis from spinal cord injuries, and autoimmune disorders. Advanced cell-based technologies can help meet the needs of an aging population, accelerate recovery from injuries, and reduce the number of people on transplant lists—currently more than 120,000. Cell-based technologies could also advance screening platforms for predictive and personalized medicine, allowing earlier treatment of some diseases such as cancer and diabetes, and could facilitate the discovery of safer and more efficient drugs. Though cells are the building blocks of all of these products, most U.S. investment in this field to date has neglected the advancement of cell manufacturing. Federal agencies—including the National Institutes of Health, Department of Defense, Department of Veterans Affairs, National Science Foundation, Food and Drug Administration, National Nuclear Security Administration, and National Institute of Standards and Technology—invested nearly $3 billion in regenerative medicine from 2012–2014, most of which was focused on basic and clinical research of new therapies. Bringing these new life-changing cell-based medical products to market critically depends on the large-scale, cost-effective, reproducible manufacturing of a variety of cell types.
Through a collaborative, strategic effort as called for in this roadmap and the support of public-private-philanthropic partnerships, the U.S. cell manufacturing industry can lead the advancement of cell manufacturing and enable the increased availability of innovative cellbased technologies. A dedicated translational effort and funding on the order of several hundred million dollars per year—or at least 10%–20% of investments in regenerative medicine—over the next 10 years would greatly accelerate this progress, maintaining the United States’ foothold in the industry and its contributions to the entire global cell manufacturing and cell-based products community.
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