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Continuous manufacturing
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How do emerging early-stage startups transition to Continuous manufacturing?
https://cmkc.usp.org/forum/defaultsection/business-case/77
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Metabolic Engineering: The Ultimate Paradigm for Continuous Pharmaceutical Manufacturing
Contributor(s):: Yadav, VG, Stephanopoulos, G
Research Article and development (R&D) expenditures by pharmaceutical companies doubled over the past decade, yet candidate attrition rates and development times rose markedly during this period. Understandably, companies have begun downsizing their pipelines and diverting investments away from...
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Hot melt extrusion technology for continuous manufacturing
Contributor(s):: Furqan Tahir, Lovett. David
Hot melt extrusion (HME), a manufacturing technique traditionally used in the plastic and food industries, is now attracting significant interest from the pharmaceutical manufacturing sector. This is primarily because HME enables the continuous manufacture of a wide variety of dosage...
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Continuous flow technology vs. the batch-by-batch approach to produce pharmaceutical compounds
Contributor(s):: Cole, KP, Johnson, MD
Introduction: For the manufacture of small molecule drugs, many pharmaceutical innovator companies have recently invested in continuous processing, which can offer significant technical and economic advantages over traditional batch methodology. This Expert Review will describe the reasons for...
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Characterization of NIR interfaces for the feeding and in-line monitoring of a continuous granulation process
Contributor(s):: Román-Ospino, Andrés D, Tamrakar, Ashutosh Igne, Benoît Dimaso, Elyse Towns Airiau, Christian Clancy, Donald J Pereira, Glinka Muzzio, Fernando J Singh, Ravendra, Ramachandran, Rohit
This work describes the characterization of three NIR interfaces intended to monitor a continuous granulation process. Two interfaces (i.e. a barrel interface and a rotating paddle interface) were evaluated to monitor the API concentration at the entrance of the granulator, and a third interface...
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Achieving continuous manufacturing in lyophilization: Technologies and approaches
Contributor(s):: Pisano, Roberto, Arsiccio, Andrea, Capozzi, Luigi C., Trout, Bernhardt L.
This paper provides an organic overview of the most interesting continuous freeze-drying concepts that have been proposed over the years. Attention has mainly been focused on the field of pharmaceuticals, but some background has also been given on the food industry. This work aims at providing a...
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Accelerating biologics manufacturing by modeling or: Is Approval under the QbD and PAT approaches demanded by authorities acceptable without a digital-twin?
Contributor(s):: Zobel-Roos, Steffen, Schmidt, Axel Mestmäcker, Fabian Mouellef, Mourad, Huter, Maximilian, Uhlenbrock, Lukas, Kornecki, Martin, Lohmann, Lara, Ditz, Reinhard, Strube, Jochen
Innovative biologics, including cell therapeutics, virus-like particles, exosomes, recombinant proteins, and peptides, seem likely to substitute monoclonal antibodies as the main therapeutic entities in manufacturing over the next decades. This molecular variety causes a growing need for a...
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A Systematic Framework for the Design and Implementation of Sensing and Control Architecture for a Continuous Pharmaceutical Manufacturing Plant
Contributor(s):: Singh, Ravendra, Muzzio, Fernando J Ierapetritou, Marianthi, Ramachnadran, Rohit
The continuous pharmaceutical manufacture (CPM) plant and control architecture developed earlier is currently being widely implemented in industries [1,2]. CPM indeed provides an appropriate platform to implement suitable monitoring and control architecture, to improve product quality, and to...
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A Combined Feed-Forward/Feed-Back Control System for a QbD-Based Continuous Tablet Manufacturing Process
Contributor(s):: Singh, Ravendra, Muzzio, Fernando J, Ierapetritou, Marianthi, Ramachandran, Rohit
Continuous pharmaceutical manufacturing together with PAT (Process Analytical Technology) provides a suitable platform for automatic control of the end product quality as desired by QbD (quality by design)-based efficient manufacturing. The precise control of the quality of the pharmaceutical...