GB/T 46490-2025 Active
GB/T 46490-2025 Biotechnology—Analytical methods—General requirements and considerations for the testing and characterization of cellular therapeutic products
Abstract
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.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 46490-2025 |
| CCS | Basic disciplines |
| ICS | Biology, botany, and zoology |
| Implement Date | 2026-05-01 |