Portable Liquid Chromatography Platform for Diverse Pharmaceutical Applications

项目摘要 液相色谱(LC)是制药行业中最重要的分析技术。 目前市场上可用的LC仪器存在成本高、体积大的缺点，这与一般的LC仪器相反 分析仪器领域的小型化趋势。Axcend公司开发了一种 重量为7公斤的紧凑型LC平台，同时仍保持与更传统的LC相似的性能 模特们。在这个快速通道SBIR项目中，Axcend公司的研究人员与毛细管LC合作 罗文大学的仪器专家，两家液晶柱制造商和几家领先的国际 制药商，将改装这种紧凑型LC仪器，以满足制药中的需求 工业。在第一阶段，仪器在色谱学方面满足监管指南的能力 将演示性能和数据审计。一旦完成，第二阶段将涉及使用 系统在一些相关的医药应用中。一种高通量梯度LC筛选方法 将被开发来识别新的化学实体中的杂质。该系统还将连接到这两批 以及用于实时在线反应监控的工艺制造流。新的毛细管色谱柱将 被开发来加强基于蛋白质的治疗药物(抗体-药物结合物，或ADC)的分离 然后应用于表征这些ADC所需的完整工作流程。所有这些目标都将在 使用Axcend紧凑型LC系统，它更小，成本更低，使用更简单，并且减少了 溶剂浪费是传统LC方法的1,000倍以上。

Project Summary Liquid chromatography (LC) is the most important analytical technique in the pharmaceutical industry. Currently available LC instruments on the market suffer from high cost and large size, contrary to the general trend of miniaturization within the field of analytical instrumentation. Axcend Corporation has developed a compact LC platform weighing 7 kg while still maintaining similar performance to the more traditional LC models. In this Fast-Track SBIR project, researchers at Axcend Corporation in collaboration with capillary LC instrumentation experts at Rowan University, two LC column manufacturers, and several leading international pharmaceutical manufacturers, will adapt this compact LC instrument to fulfill the needs in the pharmaceutical industry. In Phase I, the capability of the instrument to meet regulatory guidelines in terms of chromatographic performance and data auditing will be demonstrated. Once completed, Phase II will involve the use of the system in a number of relevant pharmaceutical applications. A high-throughput gradient LC screening method will be developed to identify impurities in new chemical entities. The system will also be coupled to both batch and process manufacturing streams for on-line reaction monitoring in real-time. New capillary LC columns will be developed to enhance the separation of protein-based therapeutics (antibody-drug conjugates, or ADCs) and then applied to the full workflow required to characterize these ADCs. All of these aims will be achieved by using the Axcend compact LC system, which is smaller, has a lower cost, is simpler to use, and reduces solvent waste over 1,000-fold over traditional LC methodology.