The regulatory challenge of 3D bioprinting.

IF 2.4 4区 医学 Q4 CELL & TISSUE ENGINEERING
Tajanka Mladenovska, Peter F Choong, Gordon G Wallace, Cathal D O'Connell
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引用次数: 2

Abstract

New developments in additive manufacturing and regenerative medicine have the potential to radically disrupt the traditional pipelines of therapy development and medical device manufacture. These technologies present a challenge for regulators because traditional regulatory frameworks are designed for mass manufactured therapies, rather than bespoke solutions. 3D bioprinting technologies present another dimension of complexity through the inclusion of living cells in the fabrication process. Herein we overview the challenge of regulating 3D bioprinting in comparison to existing cell therapy products as well as custom-made 3D printed medical devices. We consider a range of specific challenges pertaining to 3D bioprinting in regenerative medicine, including classification, risk, standardization and quality control, as well as technical issues related to the manufacturing process and the incorporated materials and cells.

3D生物打印的监管挑战。
增材制造和再生医学的新发展有可能从根本上破坏传统的治疗开发和医疗设备制造管道。这些技术给监管机构带来了挑战,因为传统的监管框架是为大规模生产的疗法而设计的,而不是定制的解决方案。3D生物打印技术通过在制造过程中包含活细胞,呈现出另一个维度的复杂性。在这里,我们概述了与现有细胞治疗产品以及定制的3D打印医疗设备相比,调节3D生物打印的挑战。我们考虑了与再生医学3D生物打印相关的一系列具体挑战,包括分类、风险、标准化和质量控制,以及与制造过程、材料和细胞相关的技术问题。
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来源期刊
Regenerative medicine
Regenerative medicine 医学-工程:生物医学
CiteScore
4.20
自引率
3.70%
发文量
82
审稿时长
6-12 weeks
期刊介绍: Regenerative medicine replaces or regenerates human cells, tissue or organs, to restore or establish normal function*. Since 2006, Regenerative Medicine has been at the forefront of publishing the very best papers and reviews covering the entire regenerative medicine sector. The journal focusses on the entire spectrum of approaches to regenerative medicine, including small molecule drugs, biologics, biomaterials and tissue engineering, and cell and gene therapies – it’s all about regeneration and not a specific platform technology. The journal’s scope encompasses all aspects of the sector ranging from discovery research, through to clinical development, through to commercialization. Regenerative Medicine uniquely supports this important area of biomedical science and healthcare by providing a peer-reviewed journal totally committed to publishing the very best regenerative medicine research, clinical translation and commercialization. Regenerative Medicine provides a specialist forum to address the important challenges and advances in regenerative medicine, delivering this essential information in concise, clear and attractive article formats – vital to a rapidly growing, multidisciplinary and increasingly time-constrained community. Despite substantial developments in our knowledge and understanding of regeneration, the field is still in its infancy. However, progress is accelerating. The next few decades will see the discovery and development of transformative therapies for patients, and in some cases, even cures. Regenerative Medicine will continue to provide a critical overview of these advances as they progress, undergo clinical trials, and eventually become mainstream medicine.
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