Industry News | China takes the lead in formulating and releasing the world's first international standard for stem cells

Date:2022-10-26
On September 24, the third China Stem Cell and Regenerative Medicine Collaborative Innovation Platform Conference and standard press Conference was held in Beijing, and a series of related standards in the field of stem cells were officially released. Including the ISO, the world's first international standard for stem cells, which China led 24603 "the general requirements for pluripotent stem cells of mice and humans", 1 item of the national standard of the general principles for sterility testing cells and the technical specification for ethical review of human stem cell research, the human natural killer cells, the midbrain dopaminergic neural precursor cells of man, the human neural stem cells and organs of the people colorectal kind, organs of the human gut kind ", "one source of stem cells outside the cell General requirements for vesicle preparation and other 7 group standards.
These international standards, national standards and standard covers group clinical and scientific research, industry, etc., ethics of stem cell research, stem cells and their derivatives of key quality attributes, quality control, such as system regulation, finally form the basic consensus in the field of stem cells in China, and is also the basis and industrialization of stem cell technology support.

Among them, ISO 24603 "Universal Requirements for Human and Mouse pluripotent Stem Cells" is the first standard for stem cells in the ISO system, which stipulates the requirements for the establishment, culture, biological characteristics, quality control, information management, distribution and transportation of pluripotent stem cells. China has issued the world's first international standard for stem cells, which has been widely concerned and highly praised by Chinese and foreign experts in the field of stem cells and standards.

On the day of the conference, China's stem cell and regenerative medicine, chairman of the collaborative innovation platform, xiu-wu bian academician of Chinese Academy of Sciences, said that "the standard is" common language "in the world, our country in the field of stem cells first to formulate relevant standards, and the development of international standards for lead, not only can regulate the scientific research practice ethical standards and specification, more achievements in scientific research and industry development is very important."

Chen Yeguang, President of the Chinese Society of Cell Biology, believed that this was a necessary and important step in the development of stem cells in China, which was of great significance to the standardization of the whole field and industry and human health.


Ji Weizhi, president of the Stem Cell Biology Branch of the Chinese Society of Cell Biology, said the release of the first international standard on stem cells shows that China has become a world leader in basic research and research on some methods and technologies in this field.

Wang Songling, academician of Stem Cell Biology Branch, believes that the release of ISO 24603 is a breakthrough for the field of stem cells and contributes Chinese wisdom and solutions to the field of stem cells around the world.

George Dagher, Convenor of the International Organization for Standardization Biotechnology Committee WG2, believes that the ISO 24603 international standard provides the requirements for the identification of the establishment and maintenance characteristics of pluripotent stem cells, which is an international consensus reached by national experts based on ISO, and is a critical and necessary step in the field of stem cells.

Christine L. Mummery, member of the International Stem Cell Society Standards Steering Committee and former president of the International Stem Cell Society, spoke highly of the achievements of the Chinese stem cell standards and expected the work of the Chinese stem cell standards to establish international benchmarks in the field of stem cells.

Glyn Stacey, member of the Biotechnology Committee of the International Organization for Standardization and member of the Standard Steering Committee of the International Stem Cell Society, believes that the process of ISO 24603 development is a difficult process that has long been full of various challenges and needs to deal with various international issues in addition to technical issues, and finally reach international consensus. The standard is the first international standard in the field of stem cells, a monumental achievement.

Zheng Jian, deputy director of the Department of Basic Research of the Ministry of Science and Technology of China, said that the ISO 24603 international standard is not only an admission certificate for the world stage of science and technology, but also provides strong support for the development of stem cell related industries, and injected a new "tonic" for the scientific and technological innovation in the field of life and health in China.

Xu Hang, deputy director of the Development Bureau of Science and Technology Promotion, Chinese Academy of Sciences, believes that ISO 24603 is the first international standard in the field of stem cells, which is led by China and participated by experts from Japan, Germany, Italy, the United Kingdom, the United States and other countries. It is also an important embodiment of China's international status in the field of stem cells.

In recent years, China has been stepping up the formulation of related standards in the field of stem cells. In the past four years, the Standards Working Committee of the Chinese Society of Cell Biology has led 16 international standard proposals, 42 national standard proposals and 24 group standard proposals. It has participated in the research of 19 international standards and 13 national standards, and played an important role in the standardization construction of stem cell field, standardizing the development of stem cell industry, protecting the rights and interests of subjects, and promoting the transformation and application of stem cells.