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Advanced Biomanufacturing: A Radical Manufacturing Paradigm Shift from Conventional, Centralized, Off-the-Shelf Production to On-Demand, Decentralized, Plug-and-Play Production of Cell- and Tissue-Based Products Kaiming Ye, and Athanassios Sambanis ACS Biomater. Sci. Eng., Just Accepted Manuscript • DOI: 10.1021/acsbiomaterials.7b00535 • Publication Date (Web): 31 Jul 2017 Downloaded from http://pubs.acs.org on August 1, 2017
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Editorial Note: Advanced Biomanufacturing: A Radical Manufacturing Paradigm Shift from Conventional, Centralized, Off-the-Shelf Production to On-Demand, Decentralized, Plug-and-Play Production of Cell- and Tissue-Based Products Current biomanufacturing, where pharmaceutical production dominates the entire bioindustry, focuses on the mass production of small molecules and therapeutic agents, such as proteins and vaccines. With the rise of regenerative therapies that utilize cell-based products, new manufacturing technologies are required to realize their full translational potential. In particular, regenerative therapies that use human stem cells pose novel challenges in developing robust and scalable cell manufacturing technologies that ensure consistent product quality. Closed system operations, automated processing of cells, and reliable testing and tracking of biological products must be addressed in order to manufacture cell therapeutics in a reproducible fashion at a medically relevant scale. Biomanufacturing of tissues from human cells presents additional challenges. The creation of highly organized multicellular constructs enables the production of functional organoids and large grafts for transplantation, disease modeling and predictive screening of new drugs for toxicity and efficacy. Since individual patients respond to therapeutic interventions differently as a result of genetic differences and the state of disease, cellular treatments need to be better tailored to individual needs. This concept of precision medicine shifts the emphasis from massive production of uniform biomedical products to high throughput parallel production of customized tissue products, each at a small scale, that have a short shelf life. Precision medicine presents significant challenges to existing biomanufacturing technologies, including product formulation preservation, testing and tracking, quality control, regulatory pathways, and supply chains. These challenges necessitate a radical manufacturing paradigm shift from conventional, centralized, offthe-shelf medicinal products to a new class of cell-based products for precision medicine. The ultimate realization of new manufacturing practices for human cell and tissue clinical application demands more basic research and technology innovations. Advanced Biomanufacturing is an emerging cross-disciplinary field that focuses on studying the use of cells or cellular products, usually in combination with natural or synthetic biomaterials, to generate biofunctional materials, devices and tissue and organ constructs. It is built upon the groundbreaking discoveries in 3D additive manufacturing, genome editing, cell programming, systems and synthetic biology, stem cell biology, computational modeling, micro- and nanofabrication, material genomes, tissue engineering and regenerative medicine. This emerging field offers tremendous opportunities to spur research, education, and industry growth and innovation.
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To foster the development of Advanced Biomanufacturing, we organized this special issue along with the Biomedical Engineering Society Advanced Biomanufacturing Special Interest Group (ABioM-SIG). The goal is to highlight advances in the field and to foster the collaboration among investigators who are working or are interested in this area. This issue is a collection of review and research articles representing the frontiers of the field. For instance, Tzanakakis and coworkers’ research presents a simple and inexpensive method for manufacturing microcarriers that support expansion of human pluripotent stem cells (hPSCs) in stirred suspension bioreactors without the use of animal-derived components. Reports by Lipke, et. al. revealed that a high efficient cardiac differentiation of human induced pluripotent stem cells within printable gelatin methacryloyl hydrogels, suggesting a possibility of biomanufactuing cardiac tissues by 3D printing. The review article by Gimble et. al. discusses the current status of adiposederived stem cells (ASCs) in cosmetic and reconstructive surgeries and in treating immune-mediated disorders. It also highlights the need for standardizing the harvesting and processing to ensure the quality of ASC-based products and procedures worldwide. The article by Wittmann and Fischbach reviews the ability of ASCs to differentiate towards tumorigenic phenotypes and the prospects of engineering 3D tumor models using ASCs and advanced biofabrication techniques. Another three of the articles in the issue discuss biomaterials developments and strategies in the context of advanced biomanufacturing. Caldorera-Moore and coworkers present the synthesis of biocompatible poly(ethylene glycol) dimethacrylate (PEGDMA)-methacrylic acid (MAA) hydrogels which have highly tunable mechanical properties, support the attachment and proliferation of pluripotent and multipotent stem cells, and could be used for the biomanufacturing of tissues of various elasticities. The article by Hsu et. al. presents the fabrication of scaffolds with biomimetic morphology which could facilitate the differentiation of neural stem cells and, potentially, be of use in nerve regenerative medicine. Zhao and coworkers provide an overview of the current approaches for biomanufacturing extracellular matrices (ECMs) from native tissues or from cultured cells and discusses the current challenges and potential solutions in the clinical application of ECM-based products. Lastly, the article by Compaan et. al. presents a new method for the efficient 3D bioprinting of cell-laden silk fibroin constructs, which was not possible before due to the slow gelation or harsh gelation conditions of the silk fibroin material. As silk fibroin is a natural protein with great promise for tissue engineering, this method offers new possibilities for the precise biomanufacturing of 3D tissues using this material. We hope these articles will provide the basis for continued cutting-edge research and innovations in this important field. Kaiming Ye, Guest Editor Athanassios Sambanis, Guest Editor
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