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Published on: May 27, 2021
Preparing for the future of precision medicine: synthetic cell drug regulation
Kira Sampson1, Carlise Sorenson1, Katarzyna P Adamala1
1Department of Genetics, Cell Biology and Development, University of Minnesota, Minneapolis, MN, USA.
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 Abstract.
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