Application of First Principles Primary Drying Model to Lyophilization Process Design and Transfer: Case Studies From the Industry
| Autor: | Scott Ewan, Serguei Tchessalov, Ted Tharp, David C. Latshaw, Melissa Bentley, Xiaodong Chen, Suresh Nulu |
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| Rok vydání: | 2020 |
| Předmět: |
Process management
Business benefits Process (engineering) Computer science Process development Collective intelligence Temperature Pharmaceutical Science Process design 02 engineering and technology 021001 nanoscience & nanotechnology 030226 pharmacology & pharmacy 03 medical and health sciences 0302 clinical medicine Freeze Drying SCALE-UP Pharmaceutical manufacturing Technology Pharmaceutical Desiccation 0210 nano-technology Transfer case |
| Zdroj: | Journal of pharmaceutical sciences. 110(2) |
| ISSN: | 1520-6017 |
| Popis: | Lyophilization modeling is well documented in academic circles but has not yet been widely adopted by pharmaceutical manufacturing companies. To facilitate wider adoption and implementation, an accessible ExcelTM-based tool is provided, presenting several fresh examples as a practical introduction to the process of modeling the primary drying phase. Case studies are presented of the tool's application during process development and scale up which highlight business benefits that have been realized by using the model. The authors and contributors are members of the BioPhorum's Lyophilization Workstream and represent several pharmaceutical companies. The current manuscript is intended to serve as a pathway to not only share the collective knowledge on the topic but also accelerate its adoption in the industry. |
| Databáze: | OpenAIRE |
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