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Biosafety considerations triggered by genome-editing technologies

Xinxin Li, Yuanjiao Gao, Ziyu Zhang, Wen‐Tao Deng, Weihua Cao, Xin Wei, Zixuan Gao, Linmei Yao, Shuojie Wang, Yao Xie, Minghui Li

2025Biosafety and Health17 citationsDOIOpen Access PDF

Abstract

• This review examines the current status and potential risks of gene editing in medicine, emphasizing the importance of policies, regulations, and technical measures to ensure its safe application. • Comprehensive analysis of genome-editing technologies:detailed exploration of current gene editing tools, including CRISPR-Cas9, TALENs, and base/prime editing, and their transformative applications in biomedicine, agriculture, and environmental science. • Critical evaluation of biosafety risks:in-depth assessment of biosafety concerns, such as off-target effects, genomic instability, and ethical challenges, particularly in germline editing. • Global regulatory frameworks and policy recommendations:examination of international regulatory frameworks and actionable policy recommendations to ensure the responsible and ethical use of genome-editing technologies. • Emerging solutions for enhanced precision:discussion of innovative approaches, such as improved CRISPR variants and engineered pegRNAs, to enhance precision and minimize unintended consequences. • Importance of public engagement:emphasis on public engagement as a critical component for ethical governance and societal acceptance of advancements in genome editing. Since the discovery of the double helix structure of deoxyribonucleic acid (DNA), significant progress has been made in engineering technologies such as gene analysis and editing, greatly promoting the development of biomedical research and clinical applications. In recent years, the rapid development of genome-editing technologies, especially the clustered regularly interspaced short palindromic repeats −associated protein 9 (CRISPR-Cas9) system, have brought unprecedented opportunities for biomedical research and clinical applications. However, with the widespread application of genome-editing technologies, biosafety issues have gradually attracted the attention of the scientific community and the public. Potential risks such as off target effects, genomic instability, and ethical and legal issues need to be taken seriously, and their safety and effectiveness in clinical applications still require further verification. This review summarizes the current status and potential risks of gene editing technologies in the medical field and discusses how to ensure its safe application through policies, regulations, and technical means. Through in-depth exploration of these issues, we hope to provide a comprehensive perspective for the scientific community, policy makers, and the public to promote the safe and responsible application of genome-editing technologies.

Topics & Concepts

BiosafetyGenome editingComputational biologyGenomeComputer scienceBiologyGeneticsBiotechnologyGeneCRISPR and Genetic EngineeringInnovation and Socioeconomic DevelopmentViral Infectious Diseases and Gene Expression in Insects
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