GB/T 15692.2-1995
Replaced
T/JFX 003-2023
Active
Group standards
T/JFX 003-2023 Recombinant Human Fc Gamma RIIIA/CD16a (V176) Protein Quality Standard
T/JFX 003-2023 Recombinant Human Fc Gamma RIIIA/CD16a (V176) Protein Quality Standard
Price:
$ 20.00
Basic Information
Standard Code:
T/JFX 003-2023
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Other standards related to pharmaceutics
Publish Date:
2024-07-22
Implement Date:
2024-07-22
Scope
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.
Development Information
Related Standards
GB/T 15692.6-1995
Replaced
GB/T 15692.6-1995 Terms of pharmaceutical machinery—Water treatment equipment for pharmaceutical use
GB/T 15692.7-1995
Replaced
GB/T 15692.7-1995 Terms of pharmaceutical machinery—Pharmaceutical packaging machinery
GB/T 15692.8-1995
Replaced
GB/T 15692.8-1995 Terms of pharmaceutical machinery—Medicine detecting instrument
GB/T 16312-1996
Abolished
GB/T 16312-1996 Chinese medicinal spray dryer system
GB/T 15692-2008
Replaced