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Abstract Synthetic cells are a novel class of cell-like bioreactors, offering the potential for unique advancements in synthetic biology and biomedicine. To realize the potential of those technologies, synthetic cell-based drugs need to go through the drug approval pipeline. Here, we discussed several regulatory challenges, both unique to synthetic cells, as well as challenges typical for any new biomedical technology. Overcoming those difficulties could bring transformative therapies to the market and will create a path to the development and approval of cutting-edge synthetic biology therapies. Graphical Abstractmore » « less
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Rothschild, Lynn_J; Averesch, Nils_J_H; Strychalski, Elizabeth_A; Moser, Felix; Glass, John_I; Cruz_Perez, Rolando; Yekinni, Ibrahim_O; Rothschild-Mancinelli, Brooke; Roberts_Kingman, Garrett_A; Wu, Feilun; et al (, ACS Synthetic Biology)
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Frischmon, Caroline; Sorenson, Carlise; Winikoff, Michael; Adamala, Katarzyna P (, Life)Build-a-Cell is a global network of researchers that aims to develop synthetic living cells within the next decade. These cells will revolutionize the biotechnology industry by providing scientists and engineers with a more complete understanding of biology. Researchers can already replicate many cellular functions individually, but combining them into a single cell remains a significant challenge. This integration step will require the type of large-scale collaboration made possible by Build-a-Cell’s open, collective structure. Beyond the lab, Build-a-Cell addresses policy issues and biosecurity concerns associated with synthetic cells. The following review discusses Build-a-Cell’s history, function, and goals.more » « less
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