T/FDSA 0055-2024 Active Group standards

T/FDSA 0055-2024 MRNA-LNP-based immunotherapy product development guideline

Publish Date: 2024-09-03 Implement Date: 2024-10-03 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/FDSA 0055-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Drugs

Publish Date: 2024-09-03

Implement Date: 2024-10-03

Scope

Main technical content: This document provides the basic principles, organization and personnel, facilities and equipment, and materials for developing (cell) immunotherapy products using mRNA-LNP technology; the technical route and process research for product development, as well as the corresponding quality control and functional verification; and basic principles and guidance suggestions for management. This document is applicable to scientific research institutions and production enterprises that develop immunotherapy products such as CAR-T or CAR-NK cells based on mRNA-LNP technology.