T/SZBMPA 002-2026 Active Group standards

T/SZBMPA 002-2026 Quality Requirements for Lyophilized Powder 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

Price: $ 20.00

Out of stock

Basic Information

Standard Code: T/SZBMPA 002-2026

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 and release of lyophilized powder of extracellular vesicles derived from human mesenchymal stromal cells, which is applicable to Investigator-Initiated Trials (IIT) and Investigational New Drug (IND) clinical trial applications. The content covers: cell collection and culture, extracellular vesicle preparation, lyophilization formulation and process, quality control and stability evaluation, packaging, storage, transportation, and labeling, etc. It provides an actionable technical basis and consistency evaluation foundation for related research and product development.