Rapid advances in synthetic biology are radically transforming multiple domains, including healthcare, agriculture, environmental management, and industrial manufacturing. Innovations in gene synthesis, modular genetic parts, AI-driven design tools, and automated cloud laboratories are dramatically lowering technical barriers to engineering living systems with unprecedented precision, scale, and speed. Open access to digital genetic sequence information and advanced DNA synthesis technologies are democratizing capabilities that were once limited to specialized facilities, thus enabling broad participation in synthetic biology research and applications.

Synthetic biology holds enormous potential to tackle pressing global challenges: from developing targeted gene and cell therapies, engineering climate-resilient crops and sustainable food sources, to designing microbes that remediate pollutants and produce renewable bio-based chemicals. However, this increasing accessibility and power come with significant ethical, social, legal, intellectual property, and biosecurity challenges that must be addressed thoughtfully.

Effective governance is critical, especially in the Global South, where biodiversity is richest and genetic resources are abundant, yet research infrastructure and policymaking capacity often lag behind. Governance frameworks should foster equitable partnerships, benefit sharing, and respect for local autonomy to avoid exacerbating global inequalities. Public engagement and education are also essential to build trust, increase transparency, and incorporate diverse societal values into synthetic biology decision-making processes.

The integration of artificial intelligence (AI) into synthetic biology further accelerates innovation, but also heightens dual-use risks. Safeguarding AI tools to prevent misuse while harnessing their potential for rapid development of vaccines, therapies, and diagnostics is vital. Advances in DNA synthesis technologies amplify concerns about dual-use by lowering technical barriers to creating harmful biological agents, demanding robust regulatory oversight and biosecurity safeguards.

The intellectual property (IP) landscape in synthetic biology presents complex challenges, blending biotechnology and software innovation. Tensions arise between the need for IP protections to incentivize investment and innovation and the desire for open access to genetic parts and tools that promote collaboration and rapid advancement. Challenges include defining patentability for novel synthetic sequences and organisms, addressing AI-assisted inventorship, and exploring alternative IP models such as open source and viral licensing to create a synthetic biology commons. These IP issues influence business models, technology transfer, and equitable access to innovations globally.

This dual-use dynamic—balancing innovation with risks—as well as governance, sustainability, equity, transparency, and IP challenges, underscores the urgent need for responsible innovation in synthetic biology.

This Research Topic examines multidisciplinary strategies to guide synthetic biology’s development through robust regulatory frameworks, ethical principles, inclusive governance models, and coherent IP policies.

By assembling cutting-edge research and expert perspectives, this topic the issue aims to provide actionable insights for balancing technological progress with risk management and equitable benefit sharing. We will highlight the critical importance of international collaboration, open yet secure access to genetic data, and transparent oversight to address the complexities arising from the democratization of powerful synthetic biological tools. Achieving this balance is essential to unlocking synthetic biology’s transformative promise sustainably, safely, and fairly—without compromising biosafety, biosecurity, public trust, or innovation incentives.

We invite original research, comprehensive reviews, policy and practice reviews, and expert perspectives that delve into these areas and more, with the aim of fostering responsible innovation that advances synthetic biology's transformative potential sustainably and ethically.

Are you interested in contributing a manuscript to this Research Topic?

Navigating Challenges and Opportunities in Synthetic Biology for Global Equity