On February 5, 2024, the China Food and Drug Enterprises Quality and Safety Promotion Association announced that the “Human Mesenchymal Stem Cell Exosome Preparation and Inspection Specifications” (No. T/FDSA 0049-2024) prepared by Shenzhen Beike Biotechnology Co., Ltd. was officially released. This group standard document is under the jurisdiction of the China Food and Drug Enterprises Quality and Safety Promotion Association and will be implemented on March 6, 2024.
T/FDSA 0049-2024 “Specifications for the Preparation and Testing of Human-Derived Mesenchymal Stem Cell Exosomes” applies to the preparation and testing of human-derived mesenchymal stem cell exosomes, and stipulates the identification methods, inspection requirements, inspection rules, labeling, packaging, storage, transportation and waste disposal requirements of human-derived mesenchymal stem cell exosomes. This standard applies to the preparation and testing of human mesenchymal stem cell exosomes.
Standardization, as a basic national system, is an important technical foundation for the national governance system and economic and social development. In order to give full play to the technical, basic and leading role of standardization work in the city’s economic and social development. As a national high-tech enterprise specializing in the clinical transformation and technical services of biotherapeutic technologies in strategic emerging industries, Beike Biotech has experienced the development of China’s cell industry. Over the years, it has always attached great importance to the standardization of cell products and has participated in dozens of national standards, local standards, group standards and other standards, covering multiple fields in the cell industry. At the same time, exosome technology is one of the seven major R&D platforms of Beike Biotechnology, and participating in the preparation of group standards is an important measure for Beike Biotech to promote this technology from scientific research and innovation results to promotion and application, and promote industrial development.
In the future, Beike Biotech will continue to invest in the standardization construction of the cell industry, actively promote the standardized construction and management of the cell industry, promote the application and industrialization development of scientific and technological innovation results, and empower the development of high-quality bio-industry.