沃特世(WAT)推出业界首款反相色谱柱 可将GLP-1表征速度提升至原来的3倍

金吾财讯
Jun 08

金吾财讯 | 全球分析仪器巨头沃特世公司(WAT)宣布推出创新的BioResolve™ Peptide和GTxResolve™ Lipid Phenyl-Hexyl+及C18+反相色谱柱平台。这是业内首款专门针对当前大热的GLP-1(胰高血糖素样肽-1)药物、胰岛素以及LNP(脂质纳米颗粒)递送系统定制的色谱柱,旨在解决生物制药领域长期存在的微量杂质分离难题。根据官方提供的数据与阿利姆比克制药(Alembic Pharmaceuticals)、阿库塔斯生物制药(Acuitas Therapeutics)等早期受测药企的反馈,该款色谱柱平台的核心商业与技术亮点包括:1)颠覆性的检测效率: 将GLP-1的表征(特性分析)速度显著提升至原先的3倍,同时将LNP的组分分析速度提升至2倍,极大缩减了生物药的质控与生产周期。2)卓越的分辨率与灵敏度: 分辨率最高可提升2倍,能够精准识别仅有单个原子差异或空间排列不同的化学同分异构体杂质,实现“单次运行(One Run)”即生成符合监管要求的合规数据。3)高度的系统兼容性: 该平台采用表面多孔颗粒设计,不仅支持先进的U(H)PLC(超高效液相色谱),还完美兼容传统HPLC(高效液相色谱)系统,药企无需更换现有的硬件管路工作流。沃特世副总裁兼消耗品与实验室自动化总经理Erin Chambers表示:“这是沃特世首次推出在出厂时就经过QC(质量控制)批次测试、专门用于GLP-1和LNP分析的色谱柱,直接解决了客户长期以来的痛点,能显著降低新型特效药的研发与生产成本。”

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