On April 3rd, it was revealed by the Shenzhen Huada Research Institute of Life Sciences (referred to as "Huada Research Institute") that the international standard "Biotechnology - Nucleic acid synthesis - Part 2: Requirements for production and quality control of synthetic gene fragments, genes, and genomes" led by China has been officially released by the International Organization for Standardization (ISO). This marks the inaugural international standard in the field of synthetic biology technology. The international standard was jointly completed by the China National Institute of Metrology and the Shenzhen Huada Research Institute of Life Sciences, among other institutions.
The standard specifies the production and quality control requirements for synthetic double-stranded DNA, outlining the quality management, resource management, biosafety, production quality control, product quality, and delivery product specifications for synthetic gene fragments, genes, and genomes. It is applicable to linear non-cloned fragments smaller than 10 Mbp (base pairs) and circular cloned gene forms in plasmids.
Synthetic biology, building upon the foundation of systems biology, involves the redesign or creation of natural or synthetic biological systems to construct a new generation of bioengineering systems. These systems are utilized in large-scale biomanufacturing technologies for pharmaceuticals, materials, and more, recognized internationally as a disruptive frontier technology and the core technology of the biomanufacturing industry.
As a focal point of competition in the international biotechnology arena, the proposal for this standard was first introduced at the ISO/TC 276 meeting in 2018. After multiple rounds of proposal, reporting, discussion, research, and revision, spanning nearly five years, the standard has finally been unanimously recognized by international experts as an International Standard (IS), contributing to China's leadership in international biotechnology standards.
