Portable Liquid Chromatography Platform for Diverse Pharmaceutical Applications

适用于多种制药应用的便携式液相色谱平台

• 批准号: 10348791
• 负责人: MILTON L. LEE
• 金额: $ 71.78万
• 依托单位: AXCEND, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10348791
• 关键词: Antibody-drug conjugates; Area; Biological Products; Blood capillaries; Chemicals; Chromatography; Collaborations; Column Chromatography; Computer software; Cost Savings; Coupled; Coupling; Data; Data Reporting; Development; Drug Industry; Gold; Guidelines; Industry Standard; Injections; International; Life Cycle Stages; Liquid Chromatography; Manufacturer Name; Mass Spectrum Analysis; Measures; Methodology; Methods; Miniaturization; Modeling; Modernization; Monitor; Monoclonal Antibodies; Performance; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacopoeias; Phase; Process; Proteins; Quality Control; Reaction; Refuse Disposal; Research; Research Personnel; Safety; Sampling; Savings; Small Business Innovation Research Grant; Solvents; Sorbus; Stream; System; Techniques; Technology; Testing; Therapeutic antibodies; Time; United States; Universities; analytical tool; base; capillary liquid chromatography; commercialization; computerized data processing; cost; data acquisition; data handling; detection limit; instrument; instrumentation; liquid chromatography mass spectrometry; manufacturing process; method development; operation; particle; portability; research and development; screening; small molecule; software systems; trend; wasting

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.

项目摘要 液相色谱（LC）是制药工业中最重要的分析技术。 目前市场上可用的LC仪器与一般的LC仪器相反，具有高成本和大尺寸的缺点。 分析仪器领域的小型化趋势。Axiom Corporation开发了一种 重量为7 kg的紧凑型LC平台，同时仍保持与传统LC相似的性能 模型在这个快速通道SBIR项目中，Axelon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LC柱制造商和几家领先的国际 制药制造商，将采用这种紧凑的LC仪器，以满足制药需求 行业在第一阶段，仪器在色谱分析方面满足监管指南的能力 将展示性能和数据审计。第二期工程完成后， 系统在许多相关的制药应用中。一种高通量梯度LC筛选方法 将开发用于识别新化学实体中的杂质。该系统还将耦合到两个批次 以及用于实时在线反应监测的工艺生产流。新型毛细管LC色谱柱将 开发用于增强基于蛋白质的治疗剂（抗体-药物缀合物或ADC）的分离 然后应用于表征这些ADC所需的完整工作流程。所有这些目标将通过以下方式实现： 使用Axelop紧凑型LC系统，体积更小，成本更低，使用更简单， 溶剂浪费超过传统LC方法1,000倍。

项目成果

Utility of low-cost, miniaturized peristaltic and Venturi pumps in droplet microfluidics.

• DOI: 10.1016/j.aca.2021.338230
• 发表时间: 2021-03-22
• 期刊: Analytica chimica acta
• 影响因子: 6.2
• 作者: Davis JJ;Padalino M;Kaplitz AS;Murray G;Foster SW;Maturano J;Grinias JP
• 通讯作者: Grinias JP

Low-cost and open-source strategies for chemical separations.

• DOI: 10.1016/j.chroma.2020.461820
• 发表时间: 2021-02-08
• 期刊: Journal of chromatography. A
• 作者: Davis JJ;Foster SW;Grinias JP
• 通讯作者: Grinias JP

Exploring Biopharmaceutical Analysis with Compact Capillary Liquid Chromatography Instrumentation.

使用紧凑型毛细管液相色谱仪器探索生物制药分析。

• DOI: 10.56530/lcgc.eu.qq7969g7
• 发表时间: 2023
• 期刊: LC GC Europe
• 作者: Libert,BenjaminP;Foster,SamuelW;Gates,ElisabethP;Morse,Matthew;Ward,Greg;Lee,MiltonL;Grinias,JamesP
• 通讯作者: Grinias,JamesP

Comparison of Design Approaches for Low-Cost Sampling Mechanisms in Open-Source Chemical Instrumentation.

开源化学仪器中低成本采样机制的设计方法比较。

• DOI: 10.1016/j.ohx.2021.e00220
• 发表时间: 2021
• 期刊: HardwareX
• 影响因子: 2.2
• 作者: Murray,Greggory;Bednarski,Samuel;Hall,Michael;Foster,SamuelW;Jin,SiJun;Davis,JoshuaJ;Xue,Wei;Constans,Eric;Grinias,JamesP
• 通讯作者: Grinias,JamesP

Online Monitoring of Small Volume Reactions Using Compact Liquid Chromatography Instrumentation.

使用紧凑的液相色谱仪器在线监测小体积反应。

• DOI: 10.1002/sscp.202200012
• 发表时间: 2022-06
• 期刊: SEPARATION SCIENCE PLUS
• 影响因子: 1.1
• 作者: Foster, Samuel W;Xie, Xiaofeng;Hellmig, Jacob M;Moura-Letts, Gustavo;West, W Raymond;Lee, Milton L;Grinias, James P
• 通讯作者: Grinias, James P