Kunlan Zuo

Synthetic biology, an evolving interdisciplinary field encompassing revolutionary technologies, requires a comprehensive consideration of bioethics, and biosafety risks to drive scientific and technological advancements. To address these concerns, it is crucial to pay attention to synthetic biology governance, ethics principles, and legal regulations, and develop appropriate biosafety risk assessment frameworks. This study endeavors to delve into the strategies of biosafety as well as the governance of risk assessment to foster innovation in the field of synthetic biology. It provides proposals to facilitate the healthy progression of synthetic biology and enhance biosafety management infrastructure. Emphasizing the critical facets of bio-risk assessment in synthetic biology, this work particularly underscores the biosafety risks associated with various factors and methods of the biosafety risk assessment. Within this context, the assessment of biosafety risk in the implementation of synthetic biology technology requires a comprehensive evaluation. Professional technical capabilities, the accessibility of the required resources and organizational scope should be considered when it comes to the actors of synthetic biology.

From the perspective of the history of science and technology, this paper delves into the global development of high-level biosafety laboratories, the establishment of related legal frameworks, and the evolution of safety standards. The importance of these laboratories within the context of national security is emphasized. This paper begins with an overview of global high-level biosafety laboratories’ origins and technological advancements. Then, it provides a detailed analysis of the legal and institutional frameworks that different countries have developed in the field of biosafety. By comparing the evolution of laboratory standards across nations, the paper illustrates how high-level biosafety laboratories have adapted to and addressed the international challenges posed by health security and biological threats. This study provides a broad review and analysis of the historical development and technological progress of these laboratories, offering insights into the construction and management of high-level biosafety laboratories. It also provides important historical perspectives for the formulation of future biosafety policies and international cooperation, contributing to the development of more effective strategies to address global biosafety challenges. This review demonstrates the critical role of high-level biosafety laboratories in safeguarding national security and global health, highlighting the continuous need for improving regulatory systems, upgrading standards, and fostering technological innovation.

From the perspective of science and technology history, we review the development history and key events of global biosafety laboratories to deepen our understanding of biosafety. The construction history of biosafety laboratories reveals the complex interactions between science, social needs, public health safety, and national security. From the recognition of laboratory infection incidents in the late 19th century to the potential hazards of biological warfare and the development of biotechnology in the mid-20th century, the gradual establishment of a laboratory biosafety level system to the construction of high-level biosafety laboratories in the 21st century to respond to global infectious disease challenges, each stage of development is closely related to the social background, technological progress, public health needs and national security considerations of the times.

This paper provides a comprehensive review of the history of laboratory-acquired infections (LAIs) from a scientific perspective on biosafety risks. It analyzes cases from the late 19th century to the 2020s, whereas the previous research on this topic has primarily focused on social factors. By combining real case studies, this study elucidates the mechanisms of LAI occurrence and development, compares the attribution of risks and mitigation measures, and establishes the scientific patterns of LAIs’ historical evolution. The details of LAI cases are compared to the biosafety risk assessment indices of the World Health Organization (WHO), the United States, and China. These real cases of LAI occurrence risks are now incorporated into biosafety standards and assessments in the modern era. Additionally, factors that pose potential risks of LAIs, even if they have not yet manifested, are also highlighted.

The history of virology, which is marked by transformative breakthroughs, spans microbiology, biochemistry, genetics, and molecular biology. From the development of Jenner’s smallpox vaccine in 1796 to 20th-century innovations such as ultrafiltration and electron microscopy, the field of virology has undergone significant development. In 1898, Beijerinck laid the conceptual foundation for virology, marking a pivotal moment in the evolution of the discipline. Advancements in influenza A virus research in 1933 by Richard Shope furthered our understanding of respiratory pathogens. Additionally, in 1935, Stanley’s determination of viruses as solid particles provided substantial progress in the field of virology. Key milestones include elucidation of reverse transcriptase by Baltimore and Temin in 1970, late 20th-century revelations linking viruses and cancer, and the discovery of HIV by Sinoussi, Montagnier, and Gallo in 1983, which has since shaped AIDS research. In the 21st century, breakthroughs such as gene technology, mRNA vaccines, and phage display tools were achieved in virology, demonstrating its potential for integration with molecular biology. The achievements of COVID-19 vaccines highlight the adaptability of virology to global health.