How Dynegene Navigates Dual-Jurisdiction DNA Synthesis Screening with commec
Dynegene, one of the world’s leading high-throughput DNA synthesis companies, operates across two of the most demanding regulatory environments in the global bioeconomy. To meet biosecurity screening expectations in both the United States and China, they needed a single, efficient tool that could do it all. Commec delivered.
The Challenge: Meeting Biosecurity Requirements across Two Regulatory Systems
Dynegene serves clients both domestically and internationally. Synthetic nucleic acids exported to the United States are delivered through WatsonBio Sciences, an exclusive third-party vendor. As an international supplier serving US customers, Dynegene is therefore expected to follow appropriate documentation, customer screening, and sequence screening practices in accordance with the OSTP Framework for Nucleic Acid Synthesis Screening.
In parallel, Chinese export control regulations create a de facto requirement for entities engaged in DNA synthesis for export to assess whether their synthesized nucleic acids fall under any listed controlled or sensitive sequences. Together, these expectations create a need for a screening approach that supports compliance with both regulatory systems while being easily integrated into Dynegene’s gene synthesis sales operations.
The Solution: Commec As a Versatile, Multi-Jurisdictional Screening Tool
The reasons behind Dynegene’s adoption of commec are straightforward. Commec is a US Framework-compliant DNA synthesis screening tool that also incorporates relevant Chinese export control considerations into its screening databases and annotations. As a free, AI-resilient, and globally accessible tool, commec supports Dynegene’s commitment to responsible innovation in synthetic biology, helping the company meet biosecurity expectations in both the United States and China.
We found commec to be very effective in guiding our sequence screening. The results are presented clearly and adopting commec has helped improve our workflow when screening sequences from all our orders.
– Eli Qu, manager of Department of Bioinformatics, Dynegene
The Outcome: Strengthened Compliance at Global Scale
Following the adoption of commec, Dynegene now supports compliance with both the US framework and relevant Chinese biosecurity requirements for DNA synthesis screening. This demonstrates the company’s commitment to industry best practices, increasing confidence in, and trust from, both domestic and US customers. Furthermore, Dynegene’s screening infrastructure is now aligned with its technological scale and operational needs.
What This Signals for the DNA Synthesis Industry
Dynegene’s example sends a strong message to the DNA synthesis industry by demonstrating in practice that screening is not only a regulatory requirement, but also a competitive advantage, both in countries with established frameworks as well as other major bioeconomies. It further shows that alignment across multiple regulatory systems is achievable with commec, helping to support best screening practices in a global context.
Working with IBBIS
IBBIS supports DNA synthesis providers operating across borders. Commec is freely available for providers seeking alignment with the US Framework, the UK screening guidance on synthetic nucleic acids for users and providers, and broader multi-jurisdictional compliance in major bioeconomies such as the European Union and the BRICS.
About Dynegene
Dynegene is an innovative Shanghai-based synthetic biology company founded in 2018 and the first company in China to commercialize next-generation, ultra-high-throughput DNA synthesis. It is one of only a few companies globally with comparable high-throughput synthesis capabilities, owning a powerful technology that positions the organization at the forefront of the global DNA synthesis market.
At the core of this capability is Dynegene’s Oligo Pool platform, which enables researchers to access up to 4.35 million custom oligos on a single chip, with lengths of up to 350 nt. The platform delivers high uniformity and >99% coverage rate, with an average error rate of approximately 1/1500. Dynegene uses no re-used chips, eliminating cross-contamination risks and ensuring batch-to-batch stability. For time-sensitive projects, Dynegene offers turnaround times as fast as 1 working day for certain scale of oligo pools.