Interpretation for the standard of Technical Guidelines for Low Temperature Preservation of Pathogenic Microorganisms for Prophylactic Biological Products

Technical Guidelines for Low Temperature Preservation of Pathogenic Microorganisms for Prophylactic Biological Products （T/CAV 002—2023, T/CAS 714—2023）have been implemented since April 10, 2023 which released by China Association for Vaccines and China Association for Standardization. This is one of the concrete and important measures to implement Biosafety Law of the People's Republic of China, the National Health Commission of the Pathogenic Microorganisms of Collection Organization of the “14^th Five-Year” Development Plan and to improve the standard system of biosafety in China. Based on the technical requirements of long-term, stable and safe preservation of pathogenic microorganism resources, the standard defines the low-temperature preservation for the first time, and refrigerated preservation, ultra-low temperature preservation, deep cryogenic preservation, freeze-drying preservation and other four low-temperature preservation methods and their definitions and operating procedures. The release and implementation of the standard will provide technical support to ensure the safety of national biological resources storage, and will also promote cryobiology basic research and the key technologies and products development, supporting the development of biological industry and biotechnology innovation such as vaccine research and development. In this paper, the background of standard compilation, the structure and main content of standard, and the application and prospect of standard are interpreted particularly, so that standard users can have a clearer understanding of the content and far-reaching significance of standard, and help the publicity and implementation of standard.