Ion Mobility Spectrometry Methods Used for On-line Measurements of Biopharmaceuti

用于生物制药在线测量的离子淌度光谱分析方法

• 批准号: 8524734
• 负责人: Ching Wu
• 金额: $ 17.06万
• 依托单位: EXCELLIMS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-10 至 2014-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8524734
• 关键词: Address; Affect; Affinity; Amino Acids; Beds; Biological; Biological Response Modifier Therapy; Biomanufacturing; Biotechnology; Cell Culture Techniques; Charge; Chemicals; Cost Savings; Culture Media; Detection; Development; Electrospray Ionization; Ensure; Escherichia coli; Feedback; Fermentation; Fingerprint; Frequencies; Gases; Goals; High Pressure Liquid Chromatography; Individual; Industry; Laboratories; Liquid Chromatography; Location; Maintenance; Manufacturer Name; Measurement; Measures; Methods; Monitor; Mono-S; Monosaccharides; Nonesterified Fatty Acids; Nutrient; Output; Performance; Pharmacologic Substance; Phase; Process; Production; Property; Research Project Grants; Sampling; Site; Small Business Innovation Research Grant; Source; Spectrometry; Speed; System; Techniques; Testing; Time; Translating; Triglycerides; Waste Products; analytical method; base; bioprocess; cost; cost effective; design; feeding; improved; innovation; insight; instrument; ion mobility; manufacturing facility; manufacturing process; mass spectrometer; method development; organic acid; prototype; public health relevance; rapid technique; research and development; research study; small molecule; tool; trend

DESCRIPTION: The ultimate goal of the Phase I SBIR project is to establish the feasibility of using ion mobility spectrometry (IMS) or liquid chromatography-IMS (LC-IMS) as a fast, selective and sensitive method for rapid monitoring of bio manufacturing processes for on-line use to improve the understanding of the process and provide real-time feedback. Excellims will develop the LC-IMS method for monitoring the most important chemical species that inform the process monitors. Bio manufacturers are limited by current real-time monitoring tools and must determine quality after the product is completed. Therefore, successful development of the method will fulfill the need for tools that increase the efficiency of the entire process that will translate into operational and cost savings for mass producing biologics.

产品说明：第一阶段SBIR项目的最终目标是确定使用离子迁移谱（IMS）或液相色谱-IMS（LC-IMS）作为快速，选择性和灵敏的方法用于在线使用的生物制造过程的快速监测的可行性，以提高对过程的理解并提供实时反馈。Excellims将开发LC-IMS方法，用于监测最重要的化学物质，为过程监测提供信息。生物制造商受到当前实时监测工具的限制，必须在产品完成后确定质量。因此，该方法的成功开发将满足对提高整个过程效率的工具的需求， 转化为大规模生产生物制剂的运营和成本节约。