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WIREs Nanomed Nanobiotechnol
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Development and regulation of exosome‐based therapy products

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Recently, various innovative therapies involving the ex vivo manipulation and subsequent reintroduction of exosome‐based therapeutics into humans have been developed and validated, although no exosome‐based therapeutics have yet to be brought into the clinic. Exosomes are nanosized vesicles secreted by many cells that utilize them for cell‐to‐cell communications to facilitate transport of proteins and genetic material. Comprised of cellular membranes with multiple adhesive proteins on their surface, exosomes offer distinct advantages that exceptionally position them as highly effective drug carriers. Additionally, exosomes can exert unique biological activity reflective of their origin that may be used for therapy of various diseases. In fact, exosomes have benefits of both synthetic nanocarriers and cell‐mediated drug delivery systems, and avoid their limitations. This concise review highlights the recent developments in exosome‐based drug delivery systems and the main regulatory considerations for using this type of therapeutic in clinic. WIREs Nanomed Nanobiotechnol 2016, 8:744–757. doi: 10.1002/wnan.1395 This article is categorized under: Therapeutic Approaches and Drug Discovery > Emerging Technologies Nanotechnology Approaches to Biology > Nanoscale Systems in Biology Toxicology and Regulatory Issues in Nanomedicine > Regulatory and Policy Issues in Nanomedicine
Overview of approach to using exosome‐based therapeutic formulations.
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The overall scheme of testing of exosome‐based drug formulations in preclinical investigations.
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Therapeutic Approaches and Drug Discovery > Emerging Technologies
Nanotechnology Approaches to Biology > Nanoscale Systems in Biology
Toxicology and Regulatory Issues in Nanomedicine > Regulatory and Policy Issues in Nanomedicine

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