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相关实验视频

Updated: Jun 20, 2025

Laboratory Scale Production and Purification of a Therapeutic Antibody

Laboratory Scale Production and Purification of a Therapeutic Antibody

Published on: January 24, 2017

重组抗体产生稳定的CHOK1池稳定性研究

Bailin Tu¹, Zhihong Lin¹, Jeff Moore¹

¹Biologics Discovery and Design, Abbott Diagnostics Division, Abbott Laboratories, Abbott Park, Illinois, USA.

Monoclonal antibodies in immunodiagnosis and immunotherapy

|July 22, 2024

概括

开发稳定的哺乳动物细胞系对于生物制造至关重要. 跳跃转化酶系统提供了一种更快,半站点特定的整合方法,用于生成高产,稳定的中国子卵巢 (CHO) 细胞池,用于体外诊断 (IVD) 生产.

关键词:

抗体制造制造抗体制造细胞培养培养的细胞培养.在体外诊断 in vitro诊断再组合的复合方式.转换酶可以转换.

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Last Updated: Jun 20, 2025

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科学领域:

生物技术是生物技术.
细胞线发展发展细胞线发展
分子生物学分子生物学

背景情况:

哺乳动物细胞系的稳定性对于生物制药和体外诊断 (IVD) 制造至关重要.
细胞系发育的传统随机整合方法耗时,可能导致遗传不稳定.
新技术旨在减轻与细胞系发育中的遗传不稳定性相关的风险.

研究的目的:

评估跳跃转化酶介导的表达系统,以产生稳定的中国仓鼠卵巢 (CHO) K1 细胞池.
评估CHO K1池的生产率和稳定性,用于生产用于IVD免疫测试的重组抗体试剂.
将特定站点集成的效率与传统的随机集成方法进行比较.

主要方法:

在CHO K1细胞中应用ATUM Leap-In转化酶系统进行半站点特定集成.
生成稳定的CHO K1细胞池,用于生产四种重组抗体试剂.
通过随着时间的推移产生一致的抗体来评估细胞系稳定性.
评估L-Glutamine对细胞系稳定性和抗体标位的影响.

主要成果:

在4个生成的CHO K1池中,有3个保持了稳定的生产率,适合制造,呈现出高抗体产量.
一个CHO K1池显示,随着时间的推移,生产率下降,但衍生克隆显示可接受的稳定性.
氨酸对细胞系/池稳定性表现出可变的影响,并显著影响了抗体产品标位.

结论:

ATUM Leap-In转化酶系统促进了用于IVD制造的高产,稳定的CHO细胞池的生成.
使用Leap-In系统的半站点特定集成可以减少与传统随机集成方法相比的开发时间.
开发的稳定池符合复合抗体生产的制造稳定性要求.