Two trends in the regulatory landscape have created new scientific opportunities and financial motivations for using process analytical technologies (PAT) in small molecule and biopharmaceutical manuf
Raman Spectroscopy in Crystallization
Two trends in the regulatory landscape have created new scientific opportunities and financial motivations for using process analytical technologies (PAT) in small molecule and biopharmaceutical manufacturing. One critical quality attribute of a pharmaceutical product, whether it is a small molecule or biopharmaceutical, is its solid-state form. Raman spectroscopy is a valuable PAT for crystallization applications such as molecular understanding of solid form, polymorphism, in situ real-time monitoring, and confirmation of the solid form. The molecular specificity, ability to be directly coupled to a reaction vessel, and compatibility with solids, liquids, gases, and turbid media are advantages of Raman spectroscopy. Readers will be introduced to recent successes in Raman-based monitoring and control of API and biopharmaceutical crystallizations.
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