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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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Addressing Barriers in Implementing Pharmaceutical Continuous Manufacturing Key Concepts & Challenges in Pharmaceutical Continuous Manufacturing
| Contributor(s):: Gabriela Grasa Mannino
Pharmaceutical continuous manufacturing (PCM) can reduce production time, decrease labor costs, and optimize process flow and the supply chain. Although some industry leaders have already invested in PCM, its widespread implementation has yet to be achieved. Major challenges to adoption include...
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Holistic Control Strategies for Continuous Manufacturing
| Contributor(s):: Moore, Christine, Garcia, Thomas, Hausner, Douglas B., Ben-Anat, Inna
Innovative technologies such as continuous manufacturing (CM) bring speed, efficiency, and agility to pharmaceutical manufacturing together with enhanced process robustness and assurance of product quality. During CM, material is simultaneously charged and discharged into process unit operations....
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Designing a novel continuous manufacturing plant with superior monitoring and control
| Contributor(s):: Singh, Ravendra, Zhang, Jun Ierapetritou, Marianthi, Ramachandran, Rohit
There is a growing interest in manufacturing the pharmaceutical product continuously . Along with other advantages , it provides an appropriate platform to implement suitable monitoring and control architecture, to improve the product quality and minimise product rejection and operating expenses....
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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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A Semi-Continuous Operations Model For Solid-Dose Manufacturing
| Contributor(s):: Pazhayattil, Ajay Babu, Sayeed-Desta, Naheed
This article will explore the evolving generic drug environment in the U.S. It will also describe an operations model for semi-continuous manufacturing of generic solid-dose products that will improve flexibility and enable just-in-time production.