{"title":"基于细胞外囊泡和外泌体的治疗方法的临床翻译和商业化指南","authors":"Ke Cheng , Raghu Kalluri","doi":"10.1016/j.vesic.2023.100029","DOIUrl":null,"url":null,"abstract":"<div><p>Extracellular vesicles (EVs) are lipid-bilayer delimited membrane structures released by cells, and play a role in intercell communication and disease development. The Global market for EVs in diagnostic and therapeutic applications is expanding. This review maps the current status of EV industry, summarizes the recent advances in EV manufacturing, and focuses on preclinical research involving EVs. The complexity and heterogeneity of EVs provide new opportunities for the development of clinical-grade EV products. The standardization of manufacturing and robust quality control must meet all the Food and Drug Administration requirements and expectations. We believe the evolution of EV research and their mass production with stringency will open a new era of EV-based products in the near future.</p></div>","PeriodicalId":73007,"journal":{"name":"Extracellular vesicle","volume":"2 ","pages":"Article 100029"},"PeriodicalIF":0.0000,"publicationDate":"2023-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Guidelines for clinical translation and commercialization of extracellular vesicles and exosomes based therapeutics\",\"authors\":\"Ke Cheng , Raghu Kalluri\",\"doi\":\"10.1016/j.vesic.2023.100029\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>Extracellular vesicles (EVs) are lipid-bilayer delimited membrane structures released by cells, and play a role in intercell communication and disease development. The Global market for EVs in diagnostic and therapeutic applications is expanding. This review maps the current status of EV industry, summarizes the recent advances in EV manufacturing, and focuses on preclinical research involving EVs. The complexity and heterogeneity of EVs provide new opportunities for the development of clinical-grade EV products. The standardization of manufacturing and robust quality control must meet all the Food and Drug Administration requirements and expectations. We believe the evolution of EV research and their mass production with stringency will open a new era of EV-based products in the near future.</p></div>\",\"PeriodicalId\":73007,\"journal\":{\"name\":\"Extracellular vesicle\",\"volume\":\"2 \",\"pages\":\"Article 100029\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-09-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Extracellular vesicle\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2773041723000082\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Extracellular vesicle","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2773041723000082","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Guidelines for clinical translation and commercialization of extracellular vesicles and exosomes based therapeutics
Extracellular vesicles (EVs) are lipid-bilayer delimited membrane structures released by cells, and play a role in intercell communication and disease development. The Global market for EVs in diagnostic and therapeutic applications is expanding. This review maps the current status of EV industry, summarizes the recent advances in EV manufacturing, and focuses on preclinical research involving EVs. The complexity and heterogeneity of EVs provide new opportunities for the development of clinical-grade EV products. The standardization of manufacturing and robust quality control must meet all the Food and Drug Administration requirements and expectations. We believe the evolution of EV research and their mass production with stringency will open a new era of EV-based products in the near future.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
