Preparing for the future of precision medicine: Synthetic cell drug regulation

Kira Sampson, Carlise Sorenson, Katarzyna P. Adamala

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish (US)
Article numberysae004
JournalSynthetic Biology
Issue number1
StatePublished - 2024

Bibliographical note

Publisher Copyright:
© 2023 The Author(s) 2024. Published by Oxford University Press.


  • artificial cells
  • cell-free protein expression
  • liposomal bioreactors
  • personalized medicine
  • synthetic cells

PubMed: MeSH publication types

  • Journal Article
  • Review


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