相关实验视频

Updated: May 7, 2026

A Quantitative Assay for Insulin-expressing Colony-forming Progenitors

A Quantitative Assay for Insulin-expressing Colony-forming Progenitors

Published on: November 28, 2011

基于细胞的检测检测天生的免疫反应调节杂质:生物类似胰岛素的应用

Cheng Her¹, Seth Thacker², Joseph Balsamo¹

¹Laboratory of Immunology, Office of Pharmaceutical Quality Research Division-IV, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.

The AAPS journal

|December 20, 2024

概括

评估胰岛素格拉和其生物类似物显示了可比的先天免疫反应. 这表明,先天性免疫反应试验可以有效地检测重组蛋白中先天性免疫调节杂质 (IIRMI) 的差异.

科学领域:

生物制药制造业生物制药制造业
免疫学免疫学免疫学
药物开发药物开发

背景情况:

生物制药的制造变化可能会改变产品的免疫性,主要是由于杂质.
天生的免疫调节杂质 (IIRMI) 可以作为辅助剂,影响免疫性风险.
目前对IIRMI的测定用于合成,但对于复杂的重组蛋白质并不广泛.

研究的目的:

为了评估胰岛素glargine及其生物类似物之间先天免疫反应的差异.
探索先天性免疫反应测试在评估重组蛋白产品中的IIRMI中的实用性.
为了为后续生物制剂的免疫性风险评估提供信息.

主要方法:

对胰岛素格拉金 (大肠杆菌) 和生物类似胰岛素 (牧羊虫) 的比较分析.
通过对90个与免疫相关的基因进行基因表达分析,评估先天免疫反应.
关键免疫媒介的量化,包括IL-1α,IL-1β,IL-6,CCL3,CCL2和CXCL8.

主要成果:

胰岛素glargine及其生物类似物都引起了类似的先天免疫反应.
在测试的免疫相关基因的表达中没有观察到显著的差异.
该研究表明,这些测试有潜力检测IIRMI.MI的差异.

结论:

天生的免疫反应测试可以为评估重组蛋白产品中的IIRMI提供有价值的数据.
相似的免疫反应表明与先天免疫调节有关的类似的杂质概况.
这些发现支持在生物类似药的监管决策中使用这种测试.

关键词:

免疫性免疫性免疫性免疫学风险评估免疫学风险评估天生的免疫反应.

更多相关视频

Homogeneous Time-resolved Förster Resonance Energy Transfer-based Assay for Detection of Insulin Secretion

Homogeneous Time-resolved Förster Resonance Energy Transfer-based Assay for Detection of Insulin Secretion

Published on: May 10, 2018

Measuring Relative Insulin Secretion using a Co-Secreted Luciferase Surrogate

Measuring Relative Insulin Secretion using a Co-Secreted Luciferase Surrogate

Published on: June 25, 2019

相关概念视频

Drug Products: Biologics, Biosimilars and Interchangeables

Drug Products: Biologics, Biosimilars and Interchangeables

Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...

Production of Pharmaceuticals

Production of Pharmaceuticals

Industrial insulin production uses genetically engineered E. coli expressing a proinsulin gene controlled by a tryptophan promoter and containing a methionine linker for later cleavage. The cells also carry ampicillin resistance for selective growth. Seed cultures are stored at −80 °C and production begins by thawing a small amount to inoculate starter cultures, which are progressively scaled to a 50,000-L bioreactor. In the bioreactor, E. coli grow in nutrient-rich media under...