GB/T 12715-1991
Abolished
GB/T 46490-2025
Active
National standards
GB/T 46490-2025 Biotechnology—Analytical methods—General requirements and considerations for the testing and characterization of cellular therapeutic products
GB/T 46490-2025 Biotechnology—Analytical methods—General requirements and considerations for the testing and characterization of cellular therapeutic products
Price:
$ 68.00
Basic Information
Standard Code:
GB/T 46490-2025
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Basic disciplines
ICS Name:
Biology, botany, and zoology
Publish Date:
2025-10-31
Implement Date:
2026-05-01
Pages:
36 pages
Scope
This document provides general requirements for the testing and characterization of cell therapy products used in humans.
This document provides methodological recommendations for the characterization of cell therapy products, including the selection and design of appropriate analytical methods for determining the key quality attributes of cell therapy products.
This document is applicable to cell starting materials (including starting materials for tissue engineering products) and intermediates of cell therapy products.
This document is not applicable to transplanted tissues.
Development Information
Adopt standards
ISO 23033:2021