Associate Professor Penn State University, United States
Introduction:: Advanced Biomanufacturing is an emerging field that focuses on the use of biological systems or the products of biological systems to generate cell and tissue therapeutic products, with a view towards scalability, standardization, and industrialization. These processes include the use of technology to generate biologically-relevant materials and systems wherein biological components and/or processes are included. The key is to utilize living building blocks, materials or synthesis systems, such as cells or related components, to exploit biological control over materials and cells such as from a structural hierarchy and complex systems/tissue assembly perspective. The anticipation is that the development of advanced cell and tissue manufacturing technologies will lead to new modes of generating biomaterials, cellular products, tissue organoids; and developing automated bioreactors and systems for a range of needs, from medical devices, biosensors, therapeutic cell and tissue products, to new ways to alter the supply chain, manufacturing environment and environmental compatibility. The scientific tools to support the vision for cell and tissue biomanufacturing have been emerging over the last decade, empowered by advances in genomics and proteomics, cell biology, regenerative medicine, 3D bioprinting, process engineering and design, and systems integration. These advances can now be targeted towards materials, cell manufacturing and tissue biofabrication in ways not even feasible ten years ago. Importantly, these opportunities are now driven by the many confounding healthcare challenges presented to society.
Materials and Methods:: Historically, biomanufacturing has focused mostly on the biologics industry, referring to fermentation, purification and formulation needs, including upstream and downstream aspects of the process. This industry continues to thrive and many of the insights and advances from the production of pharmaceuticals can be used as a guide; however, they are insufficient or not fit-for-purpose for cell and tissue engineering. The emergence of this new field offers tremendous opportunities to spur research, education, and industry growth and innovation.
Results, Conclusions, and Discussions:: To move the field forward, we need to disrupt and transform rather than settle for incremental changes. However, there are many examples of activities upon which to build, where small successes and opportunities can serve as a guide to the larger impact, eventually leading to a new sector of science discipline. The development of enabling technologies and new methods for material and cell sourcing, process modeling and integration, tissue biomanufacturing automation, on- and off-line sensing and control, tissue development and maturation, product validation and functional assays, cell and tissue preservation, regulation, and QA/QC as well as workforce training are essential to foster growth and sustain the field.