一种新型,稳定,对称的双特异抗体的工程和物理化学表征,具有双重目标结合,使用常见的轻链
Seiji Saito1, Makoto Nakayama2, Kaori Yamazaki1
1Molecular Analysis Center, R&D Division, Kyowa Kirin Co., Ltd., Tokyo, Japan.
Protein science : a publication of the Protein Society
|September 14, 2024
概括
一种新的对称双特异性抗体 (BsAb) 格式,REGULGENTTM,表现出改善的物理化学特性和高稳定性. 这一发展为高效制造和先进抗体疗法的临床应用提供了一个有前途的平台.
科学领域:
- 生物技术是生物技术.
- 免疫学 免疫学 免疫学
- 蛋白质工程是指蛋白质工程.
背景情况:
- 双特异性抗体 (BsAbs) 是一种具有治疗各种疾病潜力的重要疗法.
- 目前的BsAb开发面临着物理化学性质和制造效率方面的挑战.
- 优化对于 BsAb 的生产力和可开发性至关重要.
研究的目的:
- 开发一种具有增强性质的新型对称双特异抗体 (BsAb) 格式.
- 为应对与传统BSB格式相关的挑战,如错配和不稳定性.
- 创建一个BsAb具有有利的物理化学特征,用于商业开发.
主要方法:
- 开发一种新的对称BsAb,REGULGENTTM (N-term/C-term),使用一个共同的轻链和一个编码两个抗原结合决定因素的单个重链.
- 评估表达水平,在压力条件下聚合倾向 (低pH值),形状稳定性 (差异扫描热度计) 和抗原结合动力学 (表面等离子体共振).
主要成果:
- 在细胞培养和低pH压力期间,REGULGENTTM表现出高表达和低聚合.
- 不同扫描热量计证实了高构造稳定性,与稳定单克隆抗体相比.
- 表面等离子体共振表明,同时与两个抗原结合,具有高亲和力.
结论:
- REGULGENTTM的对称BsAb格式提供了可取的IgG类物理化学特性.
- REGULGENTTM显示了高效制造和商业发展的潜力.
- 这种新的BsAb格式对临床应用具有重大前景.
关键词:
美国国家安全委员会 DSC.这是NS-EMEM.在SPR中使用SPR.酸诱导的聚合物聚合物聚合方式 聚合方式 聚合方式抗原亲和力是一种亲和力.两种特异性抗体的抗体生产力生产力生产率的提高.稳定的稳定性 稳定的稳定性更多相关视频
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