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Continuous Manufacturing to Improve Pharmaceutical Quality: Research Examples and Opportunities
| Contributor(s):: Geng Tian
Continuous manufacturing (CM) of drug substances and drug productsProcess modeling and simulation (M&S) for CM at FDACM research highlightsOpportunities of CM for generic drug productsPharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing -...
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Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing
| Contributor(s):: Burcham, Christopher L., Florence, Alastair J., Johnson, Martin D.
The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development. The transformation has been encouraged by regulatory bodies as well as driven by cost reduction, decreased development cycles, access to new...
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Characterizing drug product continuous manufacturing residence time distributions of major/minor excipient step changes using near infrared spectroscopy and process parameters
| Contributor(s):: Shi, Zhenqi, Manley, Leo
The material residence time distribution in a continuous manufacturing process can be utilized to develop, design and justify the process control strategy. This paper successfully demonstrates using both major and minor formulation component step changes to determine the system response using...
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Achieving Continuous Manufacturing for Final Dosage Formation: Challenges and How to Meet Them
| Contributor(s):: Byrn, Stephen, Futran, Maricio, Thomas, Hayden, Jayjock, Eric, Maron, Nicola, Meyer, Robert F., Myerson, Allan S., Thien, Michael P., Trout, Bernhardt L.
We describe the key issues and possibilities for continuous final dosage formation, otherwise known as downstream processing or drug product manufacturing. A distinction is made between heterogeneous processing and homogeneous processing, the latter of which is expected to add more value to...
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A multivariate raw material property database to facilitate drug product development and enable in-silico design of pharmaceutical dry powder processes
| Contributor(s):: Van;Snick, B, Dhondt, JPandelaere, K, Bertels, J, Mertens, R, Klingeleers, D, Di, Pretoro, G, Remon, JP, Vervaet, C, De, Beer, T, Vanhoorne, V
In current study a holistic material characterization approach was proposed and an extensive raw material property database was developed including a wide variety of APIs and excipients with different functionalities. In total 55 different materials were characterized and described by over 100...