Advanced Absorbance Detection for the AUC

AUC 的高级吸光度检测

• 批准号: 6934862
• 负责人: Glen D Ramsay
• 金额: $ 10万
• 依托单位: AVIV BIOMEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-05-01 至 2006-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6934862
• 关键词: Advanced; Absorbance; Detection; AUC

DESCRIPTION (provided by applicant): The purpose of this STTR is to produce a commercially available rapid-scan absorbance optical detection system for XLA/I analytical ultracentrifuges. The currently available absorbance optical system provided by the analytical ultracentrifuge manufacturer is not optimized for sedimentation velocity analysis, the most commonly used analytical ultracentrifugation (AUC) experimental method in biomedical research. AUC is becoming the method of choice for: 1) the analysis of interacting complex systems, 2) QA/QC of biopharmaceutical products, 3) the characterization of vaccines, 4) the characterization of particle size distributions of virus solutions, and 5) the development of drug formulations. The federal Food and Drug Administration increasingly recommends that protein biologics be characterized by sedimentation velocity. It is essential that the data acquisition and manipulation software be modernized to minimize the potential for serious errors in the analysis and interpretation of data. The current absorbance system is too slow, particularly compromising data analysis for viral and vaccine samples. Current software is unable to index the thousands of data files generated, and does not record experimental setup or protocol, operator identification, or changes in the instrument conditions during an experiment, all of which can lead to confusion and errors when analyzing the results. Overcoming these limitations will allow ultracentrifugation to be used for analysis of larger particles and more complicated interacting systems. A prototype rapid-scan absorbance system has been developed that addresses these issues with a retrofit for existing instruments and vastly improved data acquisition and manipulation software. Work funded by this proposal would bring the prototype to commercial grade and integrate the hardware and software with the recently released fluorescence detection optical system. This work has the support of the base instrument manufacturer, academic researchers and pharmaceutical scientists.

描述（由申请人提供）：本STTR的目的是生产用于XLA/I分析超浓缩物的市售快速扫描吸光度光学检测系统。目前由分析超离心制造商提供的可用吸收光学系统对于沉降速度分析（生物医学研究中最常用的分析超离心（AUC）实验方法）不是最优化的。AUC正在成为以下领域的首选方法：1）相互作用的复杂系统的分析，2）生物制药产品的QA/QC，3）疫苗的表征，4）病毒溶液粒度分布的表征，以及5）药物制剂的开发。联邦食品和药物管理局越来越多地建议蛋白质生物制剂以沉降速度为特征。数据采集和处理软件必须现代化，以尽量减少数据分析和解释中出现严重错误的可能性。 目前的吸光度系统太慢，特别是危及病毒和疫苗样品的数据分析。目前的软件无法索引生成的数千个数据文件，并且不记录实验设置或协议，操作员身份或实验期间仪器条件的变化，所有这些都可能导致分析结果时的混乱和错误。克服这些限制将允许超离心用于分析更大的粒子和更复杂的相互作用系统。一个原型的快速扫描吸光度系统已经开发出来，解决了这些问题，改造现有的仪器和大大改善了数据采集和操作软件。由该提案资助的工作将使原型达到商业级，并将硬件和软件与最近发布的荧光检测光学系统集成。这项工作得到了基础仪器制造商、学术研究人员和制药科学家的支持。