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

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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.