Antibody-Membrane Switch (AMS) technology for optimized antibody engineering

摘要 高生产率细胞系的产生仍然是治疗性抗体工程的主要瓶颈。为了满足这一需求，我们开发了一种专有的抗体膜开关（AMS）技术，该技术有助于快速克隆细胞系，用于抗体的商业生产。该技术简化了高生产力克隆的鉴定，使用采用基因扩增方法的常规细胞培养技术至少缩短了6-8个月的时间。更重要的是，AMS技术允许在早期阶段评估除生产率之外的多个关键细胞系属性，从而大大简化下游工艺开发。初步研究表明，减少到实践的基本AMS方法。在第一阶段，AMS将使用两种生物仿制药抗体进行优化。在第二阶段，优化的方法将扩展到抗体库筛选。AMS技术允许抗体的发现与下游细胞系开发无缝连接，为快速、简便的细胞系生产以及新型抗体发现平台提供基础。

Abstract Generation of high productivity cell lines remains a major bottleneck in therapeutic antibody engineering. To address this need, we have developed a proprietary Antibody-Membrane Switch (AMS) technology that facilitates rapid cloning of cell lines for commercial production of antibodies. This technology streamlines identification of high-productivity clones, shaving at least 6-8 months off timelines using conventional cell culture techniques employing gene amplification methodology. More importantly, AMS technology permits assessment of multiple critical cell line attributes besides productivity in an early stage, greatly simplifying downstream process development. Preliminary studies demonstrate reduction to practice of the underlying AMS methods. In Phase I, AMS will be optimized using two biosimilar antibodies. In Phase II, the optimized methods will be extended to antibody library screening. AMS technology permits the discovery of antibodies to be seamlessly linked to downstream cell line development providing the basis for rapid, facile cell line production as well as a novel antibody-discovery platform.