BGI-Research, the core research arm of BGI Group, is proud to announce its pivotal role in developing the first-ever international standard in synthetic gene, ISO 20688-2:2024, titled "Biotechnology - Nucleic acid synthesis - Part 2: Requirements for the production and quality control of synthesized gene fragments, genes, and genomes," which has been recently published by the International Organization for Standardization (ISO).
BGI-Research co-developed ISO 20688-2:2024 "Biotechnology - Nucleic acid synthesis - Part 2: Requirements for the production and quality control of synthesized gene fragments, genes, and genomes" has been published.
ISO 20688-2:2024 meets the needs of enterprises and research institutions involved in synthetic genetics by providing a high-quality control standard essential for the advancement and consistency of synthetic biology applications. The standard specifies the requirements for the quality management, resource management, biosafety and biosecurity, quality control in production, product quality, and delivered product specifications of synthetic gene fragments, genes, and genomes with a length below 10 Mbp (base pairs) in the forms of non-clonal fragments (linear) and clonal genes in plasmids (circular).
This landmark standard, co-developed by National Institute of Metrology of China (NIM) and BGI-Research, sets a significant global benchmark for the production and quality control of synthesized genetic materials. BGI-Research has been involved since the pre-project initiation stage, offering technical support for the standard's development based on its extensive experience in synthetic biology production, research, and development. The institute’s insights on biosafety and quality control have also contributed to the wide-ranging applicability of the standard.
Previously, in 2015, BGI-Research collaborated with NIM to develop the Chinese National Standard GB/T 37873-2019 "General assessment of quality evaluation for synthesized genes." Building upon this, a team of Chinese experts presented the first international standard proposal for synthetic gene quality control in Working Group 3 (WG3) on Analytical Methods of the ISO/TC 276 Biotechnology Committee. After nearly five years of defenses, reports, discussions, research, and revisions, the proposed document was refined into an International Standard (IS) that received unanimous recognition from international experts.
Recognized as a transformative technology central to the bio-manufacturing industry, synthetic biology finds extensive use in agriculture, food production, pharmaceuticals, materials sourcing, and more. Up to 60 percent of the physical inputs to the global economy could potentially be produced biologically, and the synthetic biology market is expected to grow to between $37 billion and $100 billion by 2030.
The introduction of ISO 20688-2:2024 establishes a new precedent for quality and consistency in the global synthetic biology sector, bolstering the industry's ability to innovate safely and effectively.
Source:
ISO 20688-2:2024:
https://www.iso.org/standard/75852.html
National public service platform for standards information: General assessment of quality evaluation for synthesized genes:
https://std.samr.gov.cn/gb/search/gbDetailed?id=91890A0DA5A780C6E05397BE0A0A065D
McKinsey & Company: The Bio Revolution: Innovations transforming economies, societies, and our lives:
Nature Communications: Synthetic biology 2020–2030: six commercially-available products that are changing our world:
https://www.nature.com/articles/s41467-020-20122-2
U.S. Government Accountability Office: Science & Tech Spotlight: Synthetic Biology