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Abstract Synthetic cells are engineered vesicles that can mimic one or more salient features of life. These features include directed localization, sense‐and‐respond behavior, gene expression, metabolism, and high stability. In nanomedicine, many of these features are desirable capabilities of drug delivery vehicles but are difficult to engineer. In this focus article, we discuss where synthetic cells offer unique advantages over nanoparticle and living cell therapies. We review progress in the engineering of the above life‐like behaviors and how they are deployed in nanomedicine. Finally, we assess key challenges synthetic cells face before being deployed as drugs and suggest ways to overcome these challenges. This article is categorized under:Therapeutic Approaches and Drug Discovery > Emerging TechnologiesBiology‐Inspired Nanomaterials > Lipid‐Based Structures
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Preparing for the future of precision medicine: synthetic cell drug regulation
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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- Award ID(s):
- 1901145
- PAR ID:
- 10508263
- Publisher / Repository:
- Synthetic Biology
- Date Published:
- Journal Name:
- Synthetic Biology
- Volume:
- 9
- Issue:
- 1
- ISSN:
- 2397-7000
- Format(s):
- Medium: X
- Sponsoring Org:
- National Science Foundation
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- Free Publicly Accessible Full Text
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Accepted Manuscript1.0
- Journal Article:
- https://doi.org/10.1093/synbio/ysae004
