T/JFX 003-2023 Active
T/JFX 003-2023 Recombinant Human Fc Gamma RIIIA/CD16a (V176) Protein Quality Standard
Abstract
Main technical content: This document specifies the technical requirements, inspection rules, labeling, packaging, transportation, and storage for recombinant human Fc gamma RIIIA/CD16a (V176) protein, and describes the detection methods. This document is applicable to recombinant human Fc gamma RIIIA/CD16a (V176) protein, which is mainly used for evaluating the Fc segment effects of biopharmaceuticals such as monoclonal antibodies, bispecific antibodies, multi-specific antibodies, ADCs, and Fc fusion proteins containing the Fc segment. Different mutants have different affinities for the receptor, and the mediated antibody effects also vary. The SPR technology is used to detect the affinity of related drugs with Fc receptor protein in vitro, thereby intuitively evaluating the strength of the Fc segment's immune effect and whether it exists or not.
General Product Information
| Document Type | Group standards |
|---|---|
| Standard Status | Active |
| Standard Code | T/JFX 003-2023 |
| ICS | Other standards related to pharmaceutics |
| Implement Date | 2024-07-22 |