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 液相色谱法（LC）是制药行业中最重要的分析技术。 目前，市场上可用的LC仪器遭受高成本和大尺寸的损失，与一般 分析仪器领域中的微型化趋势。 Axcend Corporation开发了 紧凑型LC平台重7公斤，同时保持与更传统的LC相似的性能 型号。在这个Fast-Track SBIR项目中，Axcend Corporation的研究人员与毛细管LC合作 罗恩大学的仪器专家，两个LC专栏制造商和几家领先的国际 药品制造商将适应这种紧凑的LC仪器以满足药品的需求 行业。在第一阶段，仪器可以根据色谱符合监管指南的能力 将展示性能和数据审核。完成后，第二阶段将涉及使用 许多相关的药物应用中的系统。高通量梯度LC筛选方法 将开发以识别新化学实体的杂质。该系统也将连接到两个批次 和过程制造流实时进行在线反应监测。新的毛细管LC列将 可以开发以增强基于蛋白质的治疗剂（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。所有这些目标将通过 使用较小的Axcend紧凑型LC系统的成本较低，更易于使用，并且还会减少 溶剂废物超过传统LC方法超过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.

• 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