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USP Excipients Workshop: Understanding the Impact of Material Attributes on Product Quality for Continuous Manufacturing (On-Demand)
| Contributor(s):: Thomas O’Connor
For continuous manufacturing processes, the impact of variation in material attributes on material feeding and process dynamics should be characterized and appropriate controls implemented if needed.
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Quality & Regulatory Solutions for PAT in Continuous Manufacturing
| Contributor(s):: Gabriella Dahlgren, Kevin A. Macias, Antonio R. Moreira, Duncan R. Thompson, Christoph Herwig, Robert Dream
Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy with continuous manufacturing (CM) because process analytical technology can aid in implementing continuous manufacturing throughout the entire life cycle. This article discusses quality and...
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System-wide hybrid MPC–PID control of a continuous pharmaceutical tablet manufacturing process via direct compaction
| Contributor(s):: Singh, Ravendra, Ierapetritou, Marianthi, Ramachandran, Rohit
The next generation of QbD based pharmaceutical products will be manufactured through continuous processing. This will allow the integration of online/inline monitoring tools, coupled with an efficient advanced model-based feedback control systems, to achieve precise control of process variables,...
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Breaking Through Barriers to Continuous Manufacturing
| Contributor(s):: Markarian, Jennifer
Pharmaceutical manufacturing is inching towards implementing more efficient and sustainable processes, including continuous manufacturing (CM) of solid-dosage drugs. Advantages of CM include the potential for faster development, easier technical transfer, and more efficient and flexible...
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Achieving Continuous Manufacturing: Technologies and Approaches for Synthesis, Workup, and Isolation of Drug Substance May 20-21, 2014 Continuous Manufacturing Symposium
| Contributor(s):: Baxendale, IR, Braatz, RDHodnett, BK, Jensen, KF, Johnson, MD, Sharratt, P, Sherlock, JP, Florence, AJ
This whitepaper highlights current challenges and opportunities associated with continuous synthesis, workup, and crystallization of active pharmaceutical ingredients (drug substances). We describe the technologies and requirements at each stage and emphasize the different considerations for...