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Webinar : Real-time crystallization monitoring using Raman spectroscopy and kinetic models
21 November • 16h00 - 17h00 CET
Summary of the webinar
The purity of an active pharmaceutical ingredient (API) is crucial in the pharmaceutical industry. Impurities can alter the effectiveness of the drug and lead to undesirable effects. This is why pharmaceutical regulations impose strict purity standards for APIs, requiring rigorous manufacturing processes and stringent quality controls. Process analytical technology (PAT) serves as a valuable tool for real-time monitoring of product quality attributes, enhancing the overall quality control process.
In this webinar, we will present a collaborative study between Indatech and Rowan University in the USA. The study focused on the utilization of Raman spectroscopy as a PAT tool for the in-line monitoring of the crystallization process of acetaminophen, a commonly used small-molecule API, and curcumin, a simulated impurity with low solubility and co-precipitation tendencies. The Raman results were used to calibrate a population balance model, enabling the prediction of the product’s purity evolution throughout the manufacturing process.
Mitchell Paolello is a PhD student at Rowan University whose primary research interest is the diagnosis of impurity incorporation mechanisms in pharmaceutical crystallization processes. Most of his work is centered around investigating how impurities incorporate and are retained thermodynamically and kinetically, especially in the context of crystalline solid solutions. He has coauthored a published paper and submitted two papers on case studies of impurity retention mechanisms in both academic and industrial processes. His overall goal is to help improve understanding of the mechanisms in which impurity incorporation and retention occur in pharmaceutical crystallization systems with the purpose of enabling more robust process design. Before coming to Rowan, Mitchell earned his BS in Chemical Engineering at Drexel University and is also currently a co-op in the Solid State and API Engineering division at Boehringer Ingelheim.