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首页> 外文期刊>American pharmaceutical review >Near-infrared and Raman Spectroscopy: Potential Tools for Monitoring of Protein Conformational Instability during Freeze-drying Processes
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Near-infrared and Raman Spectroscopy: Potential Tools for Monitoring of Protein Conformational Instability during Freeze-drying Processes

机译：近红外和拉曼光谱：在冷冻干燥过程中监测蛋白质构象不稳定性的潜在工具

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摘要

For many biopharmaceutical drug products the last manufacturing step involves freeze-drying. As freeze-drying may be hazardous for the protein's physical stability, this step can, when not well controlled, transform a product with an acceptable quality into one to be rejected. Knowledge on the protein's conformational stability during freeze-drying processes is highly desired, as it may facilitate the development of freeze-drying cycles, increase process efficiency and create possibilities for preventing product lost. This paper discusses the suitability of Near-infrared (NIR) and Raman spectroscopy as potential in-line process analyzers for this purpose.
机译：对于许多生物制药产品，最后的制造步骤涉及冷冻干燥。由于冷冻干燥可能会危害蛋白质的物理稳定性，因此，如果不能很好地控制此步骤，则可以将质量合格的产品转变为不合格的产品。急需有关蛋白质在冻干过程中的构象稳定性的知识，因为它可以促进冻干循环的发展，提高过程效率并为防止产品损失创造可能性。本文讨论了将近红外（NIR）和拉曼光谱作为潜在的在线过程分析仪的适用性。

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