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Using online mass spectrometry to predict the end point during drying of pharmaceutical products
09 Jun 2023 | Contributor(s):: Dodda, Aditya G., Saranteas, Kostas, Henson, Michael A.
Drying of active pharmaceutical ingredients (APIs) is an energy-intensive process that is often a manufacturing bottleneck due to the relatively long processing times. A key objective is the ability to determine the drying end point, the time at which all solvent has been evaporated from the...
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Understanding API Static Drying with Hot Gas Flow: Design and Test of a Drying Rig Prototype and Drying Modeling Development
09 Jun 2023 | Contributor(s):: Ottoboni, S, Coleman, SJSteven, C, Siddique, M, Fraissinet, M, Joannes, M, Laux, A, Barton, A, Firth, P, Price, CJ, Mulheran, PA
Developing a continuous isolation process to produce a pure, dry, free-flowing active pharmaceutical ingredient (API) is the final barrier to the implementation of continuous end-to-end pharmaceutical manufacturing. Recent work has led to the development of continuous filtration and washing...
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Single-crystal Drying: Development of a Continuous Drying Prototype to Optimize Particle Flow and Residence Time Distribution
09 Jun 2023 | Contributor(s):: Zettl, M, Aigner, IHauser, C, Mannschott, T, van, der, Wel, P, Schrottner, H, Khinast, J, Krumme, M
Purpose In the pharmaceutical industry, there has been a growing interest in continuous manufacturing in recent years. Many efforts have been made to implement new process equipment for various production steps. One step which is not yet covered well is the continuous drying of the active...
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On-Demand Continuous Manufacturing of Ciprofloxacin in Portable Plug-and-Play Factories: Implementation and in Situ Control of Downstream Production
09 Jun 2023 | Contributor(s):: Capellades, Gerard, Neurohr, Clemence Briggs, Naomi Rapp, Kersten, Hammersmith, Gregory, Brancazio, David, Derksen, Bridget, Myerson, Allan S.
Traditional pharmaceutical manufacturing operates around a supply chain that is subject to complex logistics and is vulnerable to spikes in demand and interruptions. In this context, continuous pharmaceutical manufacturing in portable, refrigerator-sized factories is a promising solution with...
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Development of a Novel Continuous Filtration Unit for Pharmaceutical Process Development and Manufacturing
09 Jun 2023 | Contributor(s):: Ottoboni, S, Price, CJSteven, C, Meehan, E, Barton, A, Firth, P, Mitchell, A, Tahir, F
The lack of a commercial laboratory, pilot and small manufacturing scale dead end continuous filtration and drying unit it is a significant gap in the development of continuous pharmaceutical manufacturing processes for new active pharmaceutical ingredients (APIs). To move small-scale...
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Continuous Processing of Active Pharmaceutical Ingredients Suspensions via Dynamic Cross-Flow Filtration
09 Jun 2023 | Contributor(s):: Gursch, J, Hohl, RToschkoff, G, Dujmovic, D, Brozio, J, Krumme, M, Rasenack, N, Khinast, J
Over the last years, continuous manufacturing has created significant interest in the pharmaceutical industry. Continuous filtration at low flow rates and high solid loadings poses, however, a significant challenge. A commercially available, continuously operating, dynamic cross-flow filtration...
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Achieving continuous manufacturing in lyophilization: Technologies and approaches
09 Jun 2023 | Contributor(s):: Pisano, Roberto, Arsiccio, Andrea, Capozzi, Luigi C., Trout, Bernhardt L.
This paper provides an organic overview of the most interesting continuous freeze-drying concepts that have been proposed over the years. Attention has mainly been focused on the field of pharmaceuticals, but some background has also been given on the food industry. This work aims at providing a...
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A Novel Integrated Workflow for Isolation Solvent Selection Using Prediction and Modeling
09 Jun 2023 | Contributor(s):: Ottoboni, S, Wareham, BVassileiou, A, Robertson, M, Brown, CJ, Johnston, B, Price, CJ
A predictive tool was developed to aid process design and to rationally select optimal solvents for isolation of active pharmaceutical ingredients. The objective was to minimize the experimental work required to design a purification process by (i) starting from a rationally selected...
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A Compact Device for the Integrated Filtration, Drying, and Mechanical Processing of Active Pharmaceutical Ingredients
09 Jun 2023 | Contributor(s):: Capellades, G, Neurohr, CAzad, M, Brancazio, D, Rapp, K, Hammersmith, G, Myerson, AS
Recent changes in the pharmaceutical sector call for the development of novel manufacturing approaches to reduce costs and improve control over product quality. In this area, the development of compact, plug-and-play devices that fit in a continuous manufacturing system has gained interest in...