《预防性生物制品用病原微生物菌(毒)种低温保藏技术指南》标准解读

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

2023年4月10日,中国疫苗行业协会和中国标准化协会联合发布并实施《预防性生物制品用病原微生物菌(毒)种低温保藏技术指南》(T/CAV 002—2023、T/CAS 714—2023)。这是贯彻落实《中华人民共和国生物安全法》《人间传染的病原微生物菌(毒)种保藏机构“十四五”发展规划》中提出构建国家生物安全标准体系的重要体现。标准以病原微生物资源长期、稳定、安全保藏技术需求为出发点,首次明确了低温保藏定义,以及冷藏保藏、超低温保藏、深低温保藏、冷冻干燥保藏4种低温保藏方式及其定义和操作规范流程。标准的发布实施,将为确保国家生物资源保藏安全提供技术支撑,同时,也将推动低温生物学基础研究和关键技术与产品研发,助力疫苗研发等生物产业发展和生物科技创新。本文从标准编制背景、标准结构与主要内容、标准应用与展望3个方面对标准进行全面的解读,使标准使用者对标准的内容和作用有准确的理解,支撑标准的宣贯与实施。

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“14th 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.