XTL3710项目核心指标大幅跃升，麦科奥特原料药部门多肽工艺革新取得重大突破

MICOT

XTL3710是一款长序列多肽创新药，其固相合成通常面临偶联效率下降、缺失序列累积及杂质谱高度复杂等问题，导致粗肽纯度低、纯化收率不佳、周期长等瓶颈。

为攻克这些难题，原料药部门工艺团队在对序列的系统分析及风险评估基础上，通过多轮系统性的合成及制备纯化工艺优化，开发出一个适用于中试放大生产的工艺。最终，核心指标实现跨越式提升：粗肽纯度及收率较原工艺提高2倍，终产品的纯化收率由此提升了3倍，同时，纯化周期缩短了一半。这一双重优化极大地提高了生产效率，降低了物料及生产成本，成功实现了该复杂长序列多肽的稳定、高效生产。

XTL3710 is an innovative long-sequence peptide drug, whose solid-phase synthesis typically faces challenges such as decreased coupling efficiency, accumulation of deletion sequences, and highly complex impurity profiles, leading to bottlenecks including low crude peptide purity, poor purification yield, and long cycle times.

To overcome these difficulties, based on systematic sequence analysis and risk assessment, the process team of the API department developed a process suitable for pilot-scale production and preparative purification.

As a result, the core indicators achieved a leapfrog improvement: the purity and yield of the crude peptide increased by 2 times compared to the original process, the purification yield of the final product increased by 3 times, and the purification cycle was significantly shortened by half times.This dual optimization greatly improved production efficiency, reduced material and production costs, and successfully enabled stable and efficient production of this complex long-sequence peptide.

The successful pilot-scale production of the XTL3710 project demonstrates the company's strong capabilities in process development of complex long-peptide innovative drugs under its "innovation-driven" strategy, and lays a solid foundation for subsequent scale-up process development and cost optimization of similar long-sequence complex peptides.