On February 5, 2024, the China Food and Drug Enterprise Quality and Safety Promotion Association issued an announcement that the "Specification for the Preparation and Testing of Human-Derived Mesenchymal Stem Cell Exosomes" (No.: T/FDSA 0049—2024), co-authored with Shenzhen Beike Biotechnology Co., Ltd., has been officially released. The group standard falls under the purview of the China Food and Drug Enterprise Quality and Safety Promotion Association and will take effect on March 6, 2024.
T/FDSA 0049—2024 "Specification 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. It sets out the identification methods, testing requirements, testing rules, labeling, packaging, storage, transportation, and waste handling requirements for human-derived mesenchymal stem cell exosomes. The standard applies to the preparation and testing of human-derived mesenchymal stem cell exosomes.
Standardization, as a foundational national system, is an important technological foundation for the country's governance system and economic and social development. To fully play the technical, foundational, and leading role of standardization work in the city's economic and social development: as a national high-tech enterprise specializing in the clinical translation and technical services of biotherapy technologies in strategic emerging industries, Beike Biotech has personally witnessed the development of China's cell industry. Over the years, the company has consistently placed great importance on the standardization of cell products, having participated in the development of dozens of standards — national, local, group, and others — covering multiple areas of the cell industry. Exosome technology is one of Beike Biotech's seven major R&D platforms, and participation in the development of this group standard is an important step for Beike Biotech in moving the technology from research and innovation outcomes toward broader application and industrialization.
Going forward, Beike Biotech will continue to invest in cell industry standardization, actively promote standardized construction and management of the cell industry, advance the application and industrialization of scientific and technological innovation outcomes, and empower the high-quality development of the bio-industry.
