GB/T 38172-2019

Active

Protein A affinity chromatographic medium

蛋白A亲和层析介质

Standard Type

GBT

ICS

07.080

CCS

A21

Status

Active

Issue Date

2019-10-18

Implementation

2019-10-18

Centralized Committee

国家标准委

Issuing Authority

国家市场监督管理总局、中国国家标准化管理委员会

Application Summary AI generated

GB/T 38172-2019 specifies the technical requirements, test methods, inspection rules, and packaging for Protein A affinity chromatographic media used in biopharmaceutical manufacturing. It applies to agarose-based or polymer-based media functionalized with recombinant Protein A, primarily for the capture and purification of monoclonal antibodies and Fc-fusion proteins in downstream processing. The standard ensures consistent binding capacity, leakage control, and reusability across production batches for quality control in the pharmaceutical industry.

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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.