GB/T 38172-2019 in English

VALID

Protein A affinity chromatographic medium

Issued on:2019-10-18
Implemented on:2019-10-18
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $150.00
$146.00

Standard No:	GB/T 38172-2019
Document status:	VALID
Title in English:	Protein A affinity chromatographic medium
Title in Chinese:	蛋白A亲和层析介质
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2019-10-18
Implemented on:	2019-10-18
Professional Classification:	GB-National Standard
Related Keywords:	technological evolution protein a affinity chromatography medium affinity chromatography media chromatographic medium introduction performance indicators item indicator particle size range ratio ≥90 average particle size d/μm
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《GB/T 38172-2019蛋白A亲和层析介质》由424-cnis（中国标准化研究院）归口，主管部门为国家市场监督管理总局。

Introduction

1. Background of standard formulation and analysis of technological evolution

Protein A affinity chromatography medium is a key biological separation material, widely used in antibody drug purification and other fields. The formulation of GB/T 38172-2019 standard is based on industry needs and technological progress, aiming to standardize product quality and technical indicators to ensure its reliable application in the biopharmaceutical field.

2. Comparative analysis of standard frameworks

Dimensions	GB/T 38172—2019	Comparison with international standards	Industry status
Technical requirements	Clear appearance and performance indicators (such as particle size, flow rate)	Align with ISO standards to improve consistency	Domestic companies gradually meet the standards
Test methods	Standardize the test processes such as particle size and ligand density	Some indicators are consistent with the United States Pharmacopoeia	Laboratory technology gradually matures

3. Interpretation of the core content of the standard

3.1 Appearance requirements

Protein A affinity chromatography media should have the characteristics of full spherical shape, smooth surface, and transparency under an optical microscope. This requirement ensures the efficiency and consistency of the media during the purification process.

3.2 Performance indicators

Item	Indicator
Particle size range ratio (W)/%	≥90
Average particle size d/μm	90.0±13.5
Maximum flow rate/(cm/h)	≥300

4. Implementation suggestions and precautions

Implementation suggestions: When purchasing and using protein A affinity chromatography media, companies should strictly follow the standards for testing, focusing on key indicators such as particle size, flow rate and ligand density. It is recommended to establish a complete quality control system and calibrate the equipment regularly.

Precautions: During storage and transportation, high temperature and humidity should be avoided to prevent degradation of media performance. Before use, ensure that the media is sterile and meets the high standards of the biopharmaceutical field.

More samples: DL/T 368-2010 JGJ 94-2008 JC/T 2453-2018

Sample only — not a preview of GB/T 38172-2019

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