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Towards Continuous Primary Manufacturing Processes-Particle Design through Combined Crystallization and Particle Isolation
09 Jun 2023 | Contributor(s):: Steenweg, C, Kufner, ACHabicht, J, Wohlgemuth, K
Integrated continuous manufacturing processes of active pharmaceutical ingredients (API) provide key benefits concerning product quality control, scale-up capability, and a reduced time-to-market. Thereby, the crystallization step, which is used in approximately 90% of API productions, mainly...
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Exploring the Role of Anti-solvent Effects during Washing on Active Pharmaceutical Ingredient Purity
09 Jun 2023 | Contributor(s):: Shahid, M, Sanxaridou, GOttoboni, S, Lue, L, Price, C
Washing is a key step in pharmaceutical isolation to remove the unwanted crystallization solvent (mother liquor) from the active pharmaceutical ingredient (API) filter cake. This study looks at strategies for optimal wash solvent selection, which minimizes the dissolution of API product crystals...
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Employing Constant Rate Filtration To Assess Active Pharmaceutical Ingredient Washing Efficiency
09 Jun 2023 | Contributor(s):: Shahid, M, Faure, COttoboni, S, Lue, L, Price, C
Washing is a key step in pharmaceutical isolation to remove unwanted crystallization solvents and dissolved impurities (mother liquor) from the active pharmaceutical ingredient (API) filter cake to ensure the purity of the product whilst maximizing yield. It is therefore essential to avoid both...
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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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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...