Advanced Absorbance Detection for the AUC

描述（由申请人提供）：本STTR的目的是为XLA/I分析超离心机生产一种市售的快速扫描吸光度光学检测系统。生物医学研究中最常用的分析性超离心（AUC）实验方法——沉降速度分析，目前由分析性超离心制造商提供的吸光度光学系统并没有优化。AUC正在成为以下领域的首选方法：1)相互作用复杂系统的分析，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)药物配方的开发。联邦食品和药物管理局越来越多地建议用沉淀速度来表征蛋白质生物制品。数据采集和操作软件必须现代化，以尽量减少数据分析和解释中出现严重错误的可能性。

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.