Authors:

Urvi Mathur

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About Paper:

Process Intensification is the development of apparatus and methods that can lead to significant improvements in the manufacturing processes by reducing the equipment, waste, and cost footprint. During the pandemic, the challenge of affordable and sustainable healthcare was amplified and continues to persist even after. Hence, there is a dire need for Process Intensification in the pharmaceutical industry. The research consists of API case studies: the modular continuous synthesis and isolation of Lomustine and the optimization of Retosiban crystallization amongst impurities. Lomustine is an orphan oncology drug. The goal is to intensify the process by designing a modular continuous and small-scale manufacturing rig for Lomustine, reducing its footprint while increasing throughput. The goal for Retosiban is to reduce the waste footprint of its manufacturing process and optimize by digital twin development. The research framework relies on the corroboration of wet experiments with the digital design of the processes. To collect and analyze the results, Process Analytical Technology (PAT) such as Ultra Performance Liquid Chromatography (UPLC) will be used. Solubility curves developed from digital design twin will be fitted to the data collected from wet experimentations. With the help of parameter estimation, the digital model can be advanced to have a realistic approach that will further allow optimization. This research represents the framework for process intensification of API. Limited studies focus on the integration of the digital design twin with the experimentation results that optimizes continuous-flow- processes for API. Hence, this study can be utilized for optimization of such API. Keywords: Process Intensification; Pharmaceuticals; Crystallization; Digital Design Twin; Process Analytical Technology

Source:

Purdue University / 2024

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Co-authors:

Urvi Mathur