针对IgG类双特异抗体净化的一般策略
1Downstream Process Development (DSPD), WuXi Biologics, Shanghai, China.
Biotechnology progress
|October 16, 2024
概括
针对两个抗原的双特异性抗体 (bsAbs) 提出了独特的净化挑战. 本综述分享了开发的策略,用于净化多达70个不同的格式的bsAbs,克服常见的变体.
科学领域:
- 生物化学 生物化学
- 生物技术是生物技术.
- 免疫学 免疫学 免疫学
背景情况:
- 双特异性抗体 (bsAbs) 由于其双重向能力,比单特异性单克隆性抗体 (mAbs) 具有治疗优势.
- bsAbs的发展正在迅速扩大,有各种形式可用,特别是IgG类bsAbs.
研究的目的:
- 引入用于净化双特异抗体 (bsAbs) 的一般策略.
- 为了分享积累的经验,开发下游流程超过70个bsAbs在30多个格式.
主要方法:
- 对下游流程开发策略的审查.
- 分析与不对称和对称的IgG类bsAbs相关的净化挑战.
主要成果:
- 成功开发了超过30个格式的70多个bsAbs的下游流程.
- 在不对称的bsAbs (自由链,半分子,错误配对的物种) 和对称的bsAbs (聚合物,截断变体) 中确定了与产品相关的常见变体.
结论:
- 与传统的mAbs.相比,双特异性抗体存在更大的下游净化挑战.
- 共同的策略为净化各种格式的复杂bsAbs提供了宝贵的资源.
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