I-Corps: X-ray Diffraction based analyzer for pharmaceutical crystallization process

I-Corps项目更广泛的影响/商业潜力是缩短新药开发时间，进一步确保药品质量控制，并为制药行业提供成功的过程分析技术（PAT）工具。在制药工业中，有一种趋势是应用质量设计和PAT工具来改进药品的开发和制造。PAT是一种用于设计、分析和控制制造的系统，它使用原材料和加工材料以及制造过程的关键质量和性能属性的实时测量，以确保最终产品质量。这些PAT工具的成功开发和应用可以使制药公司加速制造过程的开发，并通过减少/消除制造错误在制造过程中建立健壮性。这个I-Corps项目建议开发一种用于药物开发和制造的药物分析系统。关键的使能技术是x射线光学产生密集的平行光束。利用平行光束的几何结构，避免了测量中的大多数标准误差来源，使测量结果更加可靠。光学光束的大尺寸也提高了数据采集中的测量统计量。该分析仪的一个关键创新是优化了整个系统配置，通过将探测器设置在固定角度（根据药物）来进行药物相测量，而不是扫描整个光谱。本文开发的方法使分析仪能够以非常高的效率连续测量药物的相。在生产过程中，无需复杂的样品制备，可在几分钟内提供信息。

The broader impact/commercial potential of this I-Corps project is to shorten the time for new drug development, further ensure the pharmaceutical product quality control, and provide a successful Process Analytical Technology (PAT) tool to the pharmaceutical industry. There is a trend in the pharmaceutical industry to apply Quality by Design and PAT tools for improving pharmaceutical drug development and manufacturing. PAT is a system for designing, analyzing and controlling manufacturing using real-time measurements of critical quality and performance attributes of raw and in-process materials and fabrication processes with the goal of ensuring final product quality. Successful development and application of these PAT tools can enable pharmaceutical firms to speed up the manufacturing process development, and build robustness into manufacturing processes by reducing/eliminating manufacturing errors.This I-Corps project proposes to develop a pharmaceutical analyzer system for use in drug development and manufacturing. The key enabling technology is an x-ray optic to generate an intensive parallel beam. By using parallel beam geometry, most of the standard sources of error in the measurements are avoided, making the measurement results more reliable. The large beam size from the optic also improves the measurement statistics in data collection. A critical innovation for this analyzer is to optimize the whole system configuration to carry out drug phase measurements by setting the detectors at fixed angles (according to the drug) rather than scanning the whole spectrum. The approach developed here enables the analyzer to continuously measure the phase of drug with very high efficiency. It would provide the information within minutes during production without complicated sample preparation.