Necessity of regulatory guidelines for the development of amyloid based biomaterials

Kumar Vijay; Sinha Nabodita; Thakur Ashwani Kumar

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Necessity of regulatory guidelines for the development of amyloid based biomaterials

机译：基于淀粉样蛋白基础生物材料的发展的必要性

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Amyloid diseases are caused due to protein homeostasis failure where incorrectly folded proteins/peptides form cross-beta-sheet rich amyloid fibrillar structures. Besides proteins/peptides, small metabolite assemblies also exhibit amyloid-like features. These structures are linked to several human and animal diseases. In addition, non-toxic amyloids with diverse physiological roles are characterized as a new functional class. This finding, along with the unique properties of amyloid like stability and mechanical strength, led to a surge in the development of amyloid-based biomaterials. However, the usage of these materials by humans and animals may pose a health risk such as the development of amyloid diseases and toxicity. This is possible because amyloid-based biomaterials and their fragments may assist seeding and cross-seeding mechanisms of amyloid formation in the body. This review summarizes the potential uses of amyloids as biomaterials, the concerns regarding their usage, and a prescribed workflow to initiate a regulatory approach.

机译：由于蛋白质稳态失效引起的淀粉样蛋白疾病，其中不正确折叠的蛋白质/肽形成富含β-片状的淀粉样蛋白原纤维结构。除蛋白质/肽外，小代谢物组件还表现出淀粉样蛋白样特征。这些结构与几种人和动物疾病相关联。此外，具有不同生理角色的无毒淀粉样蛋白的特征是一种新的功能级。这种发现以及淀粉样棒状稳定性和机械强度的独特性质，导致淀粉样蛋白基生物材料的发育激增。然而，人类和动物的使用这些材料可能会造成健康风险，例如淀粉样疾病和毒性的发展。这是可能的，因为基于淀粉样蛋白基生物材料及其片段可以有助于在体内有助于淀粉样蛋白形成的播种和交叉播种机制。本综述总结了淀粉样蛋白作为生物材料的潜在用途，对其使用的担忧以及开展监管方法的规定工作流程。

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《Biomaterials Science》 |2021年第12期|共13页
作者
Kumar Vijay; Sinha Nabodita; Thakur Ashwani Kumar;
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作者单位

Tel Aviv Univ Dept Mol Microbiol &

Biotechnol Shmunis Sch Biomed &

Canc Res George S Wise Fac Life Sci IL-69978 Tel Aviv Israel;

Indian Inst Technol Kanpur Dept Biol Sci &

Bioengn Kanpur 208016 Uttar Pradesh India;

Indian Inst Technol Kanpur Dept Biol Sci &

Bioengn Kanpur 208016 Uttar Pradesh India;

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正文语种 eng
中图分类分子生物学;
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Necessity of regulatory guidelines for the development of amyloid based biomaterials

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