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A regulatory perspective on recombinant collagen-based medical devices

As a class of novel biomaterials manufactured by synthetic biology technologies, recombinant collagens are candidates for a variety of medical applications. In this article, a regulatory scientific perspective on recombinant collagens and their medical devices is presented with a focus on the defini...

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Detalles Bibliográficos
Autores principales: Liu, Wenbo, Lin, Hai, Zhao, Peng, Xing, Lina, Li, Jie, Wang, Zehua, Ju, Shan, Shi, XinLi, Liu, Yinghui, Deng, Gang, Gao, Guobiao, Sun, Lei, Zhang, Xindong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: KeAi Publishing 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8897173/
https://www.ncbi.nlm.nih.gov/pubmed/35310384
http://dx.doi.org/10.1016/j.bioactmat.2021.10.031
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author Liu, Wenbo
Lin, Hai
Zhao, Peng
Xing, Lina
Li, Jie
Wang, Zehua
Ju, Shan
Shi, XinLi
Liu, Yinghui
Deng, Gang
Gao, Guobiao
Sun, Lei
Zhang, Xindong
author_facet Liu, Wenbo
Lin, Hai
Zhao, Peng
Xing, Lina
Li, Jie
Wang, Zehua
Ju, Shan
Shi, XinLi
Liu, Yinghui
Deng, Gang
Gao, Guobiao
Sun, Lei
Zhang, Xindong
author_sort Liu, Wenbo
collection PubMed
description As a class of novel biomaterials manufactured by synthetic biology technologies, recombinant collagens are candidates for a variety of medical applications. In this article, a regulatory scientific perspective on recombinant collagens and their medical devices is presented with a focus on the definition, translation, classification and technical review. Recombinant collagens are categorized as recombinant human collagen, recombinant humanized collagen and recombinant collagen-like protein, as differentiated by specific compositions and structures. Based on their intended uses and associated risks, recombinant collagen-based medical devices are generally classified as Class Ⅱ or Ⅲ in China. The regulatory review of recombinant collagen-based medical devices aims to assess their safety and efficacy demonstrated by scientific evidences generated from preclinical and clinical evaluations. Taken together, opportunities as well as challenges for their future clinical translation of recombinant collagen-based medical devices abound, which highlights the essential role of regulatory science to provide new tools, standards, guidelines and methods to evaluate the safety and efficacy of medical products.
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spelling pubmed-88971732022-03-17 A regulatory perspective on recombinant collagen-based medical devices Liu, Wenbo Lin, Hai Zhao, Peng Xing, Lina Li, Jie Wang, Zehua Ju, Shan Shi, XinLi Liu, Yinghui Deng, Gang Gao, Guobiao Sun, Lei Zhang, Xindong Bioact Mater Perspective As a class of novel biomaterials manufactured by synthetic biology technologies, recombinant collagens are candidates for a variety of medical applications. In this article, a regulatory scientific perspective on recombinant collagens and their medical devices is presented with a focus on the definition, translation, classification and technical review. Recombinant collagens are categorized as recombinant human collagen, recombinant humanized collagen and recombinant collagen-like protein, as differentiated by specific compositions and structures. Based on their intended uses and associated risks, recombinant collagen-based medical devices are generally classified as Class Ⅱ or Ⅲ in China. The regulatory review of recombinant collagen-based medical devices aims to assess their safety and efficacy demonstrated by scientific evidences generated from preclinical and clinical evaluations. Taken together, opportunities as well as challenges for their future clinical translation of recombinant collagen-based medical devices abound, which highlights the essential role of regulatory science to provide new tools, standards, guidelines and methods to evaluate the safety and efficacy of medical products. KeAi Publishing 2021-10-29 /pmc/articles/PMC8897173/ /pubmed/35310384 http://dx.doi.org/10.1016/j.bioactmat.2021.10.031 Text en © 2021 The Authors https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Perspective
Liu, Wenbo
Lin, Hai
Zhao, Peng
Xing, Lina
Li, Jie
Wang, Zehua
Ju, Shan
Shi, XinLi
Liu, Yinghui
Deng, Gang
Gao, Guobiao
Sun, Lei
Zhang, Xindong
A regulatory perspective on recombinant collagen-based medical devices
title A regulatory perspective on recombinant collagen-based medical devices
title_full A regulatory perspective on recombinant collagen-based medical devices
title_fullStr A regulatory perspective on recombinant collagen-based medical devices
title_full_unstemmed A regulatory perspective on recombinant collagen-based medical devices
title_short A regulatory perspective on recombinant collagen-based medical devices
title_sort regulatory perspective on recombinant collagen-based medical devices
topic Perspective
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8897173/
https://www.ncbi.nlm.nih.gov/pubmed/35310384
http://dx.doi.org/10.1016/j.bioactmat.2021.10.031
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