T/SZJCH 0003-2022 Active Group standards

T/SZJCH 0003-2022 Cell-derived exosome generic technical requirements

Publish Date: 2022-04-29 Implement Date: 2022-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/SZJCH 0003-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Comprehensive Pharmaceutical Science

Publish Date: 2022-04-29

Implement Date: 2022-05-01

Scope

Main technical content: Exosomes are vesicular structures secreted by living cells into the extracellular environment, formed through two inward invaginations of the cell plasma membrane. In recent years, exosomes have been widely applied in scientific research and clinical trials, and hold great promise in early disease diagnosis and prognosis, drug delivery systems, and novel therapeutic formulations. The extraction and identification of exosomes are the cornerstone of their application, and stable, uniform preparation and detection techniques are crucial for the continuous development of exosome research and practical applications. However, there are currently no universal technical requirements for exosome extraction, identification, and quality control in China or abroad. To promote the development of exosome scientific research and practical applications, and to unify the common technical requirements for exosome extraction, identification, and quality control, this document was developed based on domestic and international exosome-related literature, normative and guidance documents, expert consensus, and the scientific research and application experience of participating units. As a new research object, exosomes are expanding their application directions and sub-fields. As a useful attempt and exploration in formulating universal technical requirements for exosomes, the main purpose of this document is to provide an entry-level reference for scientists and product developers new to this field, and to bridge the gap between laboratory technology and industrialization. The document lists the most widely accepted consensus on exosome preparation, identification, and quality control in the industry at this stage, providing the most universal reference for translating exosome technology achievements from laboratory to industrial applications. To better adapt to the development of exosome scientific research and clinical translation applications, the document i