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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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Integrated continuous manufacturing in pharmaceutical industry: current eolutionary steps toward revolutionary future
| Contributor(s):: Nada A Helal, Ola Elnoweam, Heba Abdullah Eassa, Ahmed M Amer, Mohamed Ashraf Eltokhy, Mohamed A Helal, Heba A Fayyaz, Mohamed Ismail Nonou
Continuous manufacturing (CM) has the potential to provide pharmaceutical products with better quality, improved yield and with reduced cost and time. Moreover, ease of scale-up, small manufacturing footprint and on-line/in-line monitoring and control of the process are other merits for CM....
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Inline UV/Vis spectroscopy as PAT tool for hot-melt extrusion
| Contributor(s):: Wesholowski, Jens, Prill, Sebastian, Berghaus, Andreas, Thommes, Markus
Hot-melt extrusion on co-rotating twin screw extruders is a focused technology for the production of pharmaceuticals in the context of Quality by Design. Since it is a continuous process, the potential for minimizing product quality fluctuation is enhanced. A typical application of hot-melt...
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ICAS-PAT: A software for design, analysis and validation of PAT systems
| Contributor(s):: Singh, Ravendra, Gernaey, Krist V, Gani, Rafiqul
In chemicals based product manufacturing, as in pharmaceutical, food and agrochemical industries, efficient and consistent process monitoring and analysis systems (PAT systems) have a very important role. These PAT systems ensure that the chemicals based product is manufactured with the specified...
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Deep learning for continuous manufacturing of pharmaceutical solid dosage form
| Contributor(s):: Roggo, Yves, Jelsch, Morgane, Heger, Philipp, Ensslin, Simon, Krumme, Markus
Continuous Manufacturing (CM) of pharmaceutical drug products is a new approach within the pharmaceutical industry. In the presented paper, a GMP continuous wet granulation line for production of solid dosage forms was investigated. The line was composed of the subsequent continuous unit:...
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Design of Condition-based Maintenance Framework for Process Operations Management in Pharmaceutical Continuous Manufacturing
| Contributor(s):: Ganesh, Sudarshan, Su, Qinglin, Vo, Le Bao Dan, Pepka, Nolan, Rentz, Benjamin, Vann, Lucas, Yazdanpanah, Nima, O'Connor, Thomas, Nagy, Zoltan K., Reklaitis, Gintaras V.
Continuous manufacturing, an emerging technology in the pharmaceutical industry, has the potential to increase the efficiency, and agility of pharmaceutical manufacturing processes. To realize these potential benefits of continuous operations, effectively managing materials, equipment, analyzers,...
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Continuous manufacturing process monitoring of pharmaceutical solid dosage form: A case study
| Contributor(s):: Roggo, Yves, Pauli, Victoria, Jelsch, Morgane, Pellegatti, Laurent, Elbaz, Frantz, Ensslin, Simon, Kleinebudde, Peter, Krumme, Markus
The most prevalent pharmaceutical dosage forms at present are granular solids in the form of oral tablets and capsules. While effective in releasing drug rapidly upon contact with gastrointestinal fluid, their manufacture, which relies on particulate processing, is fraught with difficulties...
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An ontological knowledge-based system for the selection of process monitoring and analysis tools
| Contributor(s):: Singh, Ravendra, Gernaey, Krist V, Gani, Rafiqul
Efficient process monitoring and analysis tools provide the means for automated supervision and control of manufacturing plants and therefore play an important role in plant safety, process control and assurance of end product quality. The availability of a large number of different process...
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Analysing drying unit performance in a continuous pharmaceutical manufacturing line by means of mass - Energy balances
| Contributor(s):: Mortier, Severine Therese F. C., Gernaey, Krist V., De Beer, Thomas, Nopens, Ingmar
The current trend in the pharmaceutical industry to move from batch-wise to continuous production processes strengthens the need for monitoring and controlling the process in-line. The ConsiGma(Tm) continuous tableting line collects data of the different subunits in real-time, but these are not...
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Advances in Continuous Active Pharmaceutical Ingredient (API) Manufacturing: Real-time Monitoring Using Multivariate Tools
| Contributor(s):: Dumarey, Melanie, Hermanto, Martin, Airiau, Christian, Shapland, Peter, Robinson, Hannah, Hamilton, Peter, Berry, Malcom
Purpose: The implementation of continuous processing technologies for pharmaceutical manufacturing has increased due to its potential to enhance supply chain flexibility, reduce the footprint of the manufacturing facility, and deliver more consistent quality. Additionally, it facilitates...