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Unveiling the Complex World of Extracellular Vesicles: Novel Characterization Techniques and Manufacturing Considerations.
Lai, James J; Hill, John J; Huang, Casey Y; Lee, Gino C; Mai, Karol W; Shen, Maggie Y; Wang, Simon K.
Afiliación
  • Lai JJ; Department of Bioengineering, University of Washington, Seattle, WA, USA.
  • Hill JJ; Department of Materials Science and Engineering, National Taiwan University of Science and Technology, Taipei, Taiwan.
  • Huang CY; Department of Bioengineering, University of Washington, Seattle, WA, USA.
  • Lee GC; Department of Materials Science and Engineering, National Taiwan University of Science and Technology, Taipei, Taiwan.
  • Mai KW; Department of Medicinal Chemistry, University of Washington, Seattle, WA, USA.
  • Shen MY; BioProcess Technology Group, BDO, Boston, MA, USA.
  • Wang SK; Department of Bioengineering, University of Washington, Seattle, WA, USA.
Chonnam Med J ; 60(1): 1-12, 2024 Jan.
Article en En | MEDLINE | ID: mdl-38304124
ABSTRACT
Extracellular vesicles (EVs) function as potent mediators of intercellular communication for many in vivo processes, contributing to both health and disease related conditions. Given their biological origins and diverse functionality from correspondingly unique "cargo" compositions, both endogenous and modified EVs are garnering attention as promising therapeutic modalities and vehicles for targeted therapeutic delivery applications. Their diversity in composition, however, has revealed a significant need for more comprehensive analytical-based characterization methods, and manufacturing processes that are consistent and scalable. In this review, we explore the dynamic landscape of EV research and development efforts, ranging from novel isolation approaches, to their analytical assessment through novel characterization techniques, and to their production by industrial-scale manufacturing process considerations. Expanding the horizon of these topics to EVs for in-human applications, we underscore the need for stringent development and adherence to Good Manufacturing Practice (GMP) guidelines. Wherein, the intricate interplay of raw materials, production in bioreactors, and isolation practices, along with analytical assessments compliant with the Minimal Information for Studies of Extracellular Vesicles (MISEV) guidelines, in conjunction with reference standard materials, collectively pave the way for standardized and consistent GMP production processes.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Guideline Idioma: En Revista: Chonnam Med J Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Corea del Sur

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Guideline Idioma: En Revista: Chonnam Med J Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Corea del Sur