T/SZBMPA 003-2026 Active Group standards

T/SZBMPA 003-2026 Quality Requirements for Small-and Pilot-scale Production of Human Mesenchymal Stromal Cell-Derived Extracellular Vesicles

Publish Date: 2026-01-13 Implement Date: 2026-01-13 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/SZBMPA 003-2026

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Biological products and blood products

ICS Name: Drugs

Publish Date: 2026-01-13

Implement Date: 2026-01-13

Scope

This document specifies the quality requirements for the preparation of extracellular vesicles derived from human mesenchymal stromal cells during the Investigator-Initiated Trial (IIT) and Investigational New Drug Application (IND) stages, covering aspects such as cell collection and cultivation, extracellular vesicle separation and purification, quality requirements, packaging, storage, transportation, and labeling. It provides a reference basis for related research and product development.