China is home to some of the world’s largest DNA synthesis capacity, and its active involvement in shaping these standards is an important step toward global coverage. To learn more about what this engagement looks like in practice, IBBIS spoke with Dr. Shen Yue, Chief Scientist of Synthetic Biology at BGI-Research and an important contributor to the DNA Synthesis Screening Consortium (DSSC) – China workstream.
Q: Could you tell us a little about your work at BGI-Research and what drew you to participate in the DSSC?
At BGI-Research, my work focuses on pushing the boundaries of synthetic biology, particularly in large-scale genome engineering and the development of next-generation DNA synthesis platforms. Since 2010, I have been a core participant in the International Synthetic Yeast Genome Project (Sc2.0), where my team was responsible for the de novo design and synthesis of multiple yeast chromosomes. This experience provided us with deep, hands-on insights into the complexities of DNA synthesis at a genomic scale. Furthermore, I led the development of a high-throughput DNA synthesis system based on chip-sorting principles (mMPS, PMID: 41034496), aimed at making these enabling technologies more efficient and accessible.
However, as sequencing becomes ubiquitous and synthesis technology matures, the technical barriers to entry are rapidly lowering. We recognized early on that while DNA synthesis is a foundational ‘enabling technology’ for the global bioeconomy, its democratization brings significant responsibilities. How we ensure this technology is used as a force for good is critical. This realization led us to focus intensely on the necessity of pre-synthesis sequence screening from both biosafety and biosecurity perspectives. Since 2018, in collaboration with the National Institute of Metrology of China (NIM), I have been deeply involved in driving the development of international standards for gene synthesis. A milestone of this effort was the publication of ISO 20688-2:2024. During that process, through extensive dialogue with global experts, we reached a vital consensus: risk identification must be an integral component of the synthesis workflow. We successfully introduced the ‘Biosafety Framework’ into this international standard for the first time.
What drew me to the DSSC is the opportunity to bridge the gap between these high-level standards and practical, global implementation. I view the framework established in ISO 20688-2:2024 as the technical bedrock for the DSSC’s mission. In addition, from a DNA synthesis service provider’s perspective, screening is also a vital part of internal risk management and employee protection. Since manufacturing staff are the first to handle synthesized sequences, a robust screening system serves as an essential safeguard for their occupational safety. By joining this consortium, I hope to contribute my technical expertise to refine these screening protocols and ensure they are not only robust and scientifically sound but also practically implementable for providers worldwide, ultimately safeguarding the future of the bioeconomy.
Q: What do you think about the relationship between DNA synthesis screening and China’s ambitions in synthetic biology and the bioeconomy?
China’s ambitions in synthetic biology and the bioeconomy are built on the twin pillars of innovation and responsibility. As synthetic biology was formally designated a frontier priority in our 14th Five-Year Plan and the subsequent National Bioeconomy Development Plan (2022), we recognized that the scale of our ambition necessitates an equally robust commitment to biosecurity. I view the relationship between DNA synthesis screening and these national goals through two lenses: the Macro-Strategic and the Micro-Technical.
From a Macro-Strategic perspective, screening is not a hurdle to the bioeconomy; it is its foundational insurance. China’s transition toward a high-quality bioeconomy requires international trust and seamless global collaboration. By adhering to and helping define rigorous screening standards, Chinese biotechnology can ensure it operates within a ‘safe harbor.’ The Biosecurity Law of 2021 provides the legal mandate for this, emphasizing that development and security must progress in tandem. For China to lead in the global bioeconomy, our synthetic biology ecosystem must be seen as a reliable, secure, and transparent partner. DNA screening is the primary mechanism that builds this global confidence.
From a Micro-Technical perspective, I see screening as a critical technical requirement for scalability. As we increase synthesis capacity by orders of magnitude, we also increase the potential for accidental or intentional misuse if oversight remains manual or fragmented. The work on ISO 20688-2:2024 was driven by the need for clear, computable standards that allow for automated, high-speed screening. This is essential for the high-throughput foundries China is building in several cities.
In summary, DNA synthesis screening is the operating system of a responsible bioeconomy. For China to achieve its goal of becoming a global hub for bio-innovation, we must ensure that our technical capabilities in synthesis are matched by our leadership in biosecurity standards. The work of the DSSC is vital in ensuring that these standards are harmonized globally, allowing the Chinese bioeconomy to thrive in a secure and interconnected world.
Q: Are there examples from China’s approach to DNA synthesis screening that you think the international community could learn from or adopt as best practice?
I believe the most significant example the international community can draw from China is the top-down legislative framework for biosecurity. While many jurisdictions currently rely on voluntary industry self-regulation or departmental guidelines, China has established a comprehensive statutory obligation through the 2021 Biosecurity Law. Specifically, Article 38 of this law mandates that entities providing biotechnological services and products must implement robust risk categorization and management protocols. This legal anchor is a critical best practice for two reasons:
First, it creates a ‘level playing field.’ By codifying biosecurity requirements into national law, it ensures that screening is not merely a voluntary ‘best practice’ adopted by leading companies, but a mandatory baseline for all providers within the ecosystem. This prevents a ‘race to the bottom’ where biosecurity might otherwise be compromised for competitive advantage.
Second, it provides clear accountability. The law explicitly identifies synthetic biology (under Article 60) as a frontier area requiring vigilant monitoring and risk assessment. This foresight ensures that as synthesis technologies continue to scale, the legal responsibility to screen and report ‘Sequences of Concern’ remains a front-line defense.
By integrating these requirements into a unified national law, China has demonstrated how to provide the legal certainty and enforcement neutrality necessary for a responsible bioeconomy.
Q: How do you see China’s role evolving in international biosecurity standard-setting?
I see China evolving from a participant into a proactive technical contributor and a bridge for international biosecurity standards. Given the scale of China’s DNA synthesis industry and high-throughput foundry capabilities, China serves as a unique ‘testing ground’ for the feasibility of these standards. Moving forward, China’s role will be to share the practical insights gained from aligning domestic operations with the 2021 Biosecurity Law and our experience in developing ISO 20688-2:2024.
Q: What would success look like for the China workstream and for DSSC as a whole in two to three years?
Success for the China workstream would mean achieving a broad industry consensus where the ‘baseline screening standards’ are seamlessly integrated into the workflows of all domestic providers, moving from legal requirement to operational habit. For the DSSC as a whole, success would be the successful publication and global adoption of the supplementary guide to ISO 20688-2. We will have moved past fragmented practices toward a harmonized global ecosystem where the 50nt screening threshold is the norm. Ultimately, success means we have ‘raised the floor’ of global biosecurity without stifling the pace of bio-innovation, ensuring a secure and transparent supply chain for the global bioeconomy.