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Systematic investigation of the impact of screw elements in continuous wet granulation
10 Sep 2024 | Peer-reviewed journal | Contributor(s): Katharina Kiricenko, Peter Kleinebudde, Robin Meier
Twin-screw wet granulation (TSG) is a continuous manufacturing technique either for granules as final dosage form or as an intermediate before tableting or capsule filling. A comprehensive process understanding is required to implement TSG, considering various parameters influencing granule and...
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The Rise of Continuous Manufacturing in Pharma
13 Aug 2024 | Website | Contributor(s): Editorial Team
"Mr Indu Bhushan, CEO and Director of STEERLife shares his insights on the transformative journey of continuous manufacturing, and the advanced technologies that have propelled this paradigm shift. He also throws light on how continuous manufacturing has accelerated drug development...
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Critical review on the role of excipient properties in pharmaceutical powder-to-tablet continuous manufacturing
13 Aug 2024 | Peer-reviewed journal | Contributor(s): Sara Fathollahi, Pauline H. M. Janssen, Bastiaan H. J. Dickhoff, Henderik W. Frijlink
The pharmaceutical industry is gradually changing batch-wise manufacturing processes to continuous manufacturing processes, due to the advantages it has to offer. The final product quality and process efficiency of continuous manufacturing processes is among others impacted by the properties of...
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Process intensification of pharmaceutical powder blending at commercial throughputs by utilizing semi-continuous mini-blending
13 Aug 2024 | Peer-reviewed journal | Contributor(s): Maarten Jaspers, Florian Tegel, Timo P. Roelofs, Fabian Starsich, Yunfei Li Song, Bernhard Meir, Richard Elkes, Bastiaan H.J. Dickhoff
Process intensification involves the miniaturization of equipment while retaining process throughput and performance. The pharmaceutical industry can benefit from this approach especially during drug product development, where the availability of active pharmaceutical ingredients (API) is often...
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Continuous Manufacturing in the Pharmaceutical Industry: Enhancing Drug Production
23 Jul 2024 | Website | Contributor(s): Timmerman, Siebe
A significant shift towards continuous manufacturing (CM) is currently underway in the pharmaceutical industry. Unlike the more commonly used batch processing, CM operates continuously. This method potentially offers increased efficiency, agility, and flexibility in the manufacturing of drug...
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Process analytics for the new era of continuous RNA manufacturing
23 Jul 2024 | Website | Contributor(s): Botonjic-Sehic, Edita
In this article, Edita Botonjic-Sehic, Head of Process Analytics and Data Science at ReciBioPharm, examines the need for a digitally controlled continuous manufacturing process to correct the shortcomings of the current standard of batch processing. She highlights the critical role in-line...
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Improvement of a pharmaceutical powder mixing process in a tote blender via DEM simulations
04 Jun 2024 | Peer-reviewed journal | Contributor(s): Benedict Benque, Luca Orefice, Thomas Forgber, Matthias Habeler, Beate Schmid, Johan Remmelgas, Johannes Khinast
An industrial-scale pharmaceutical powder blending process was studied via discrete element method (DEM) simulations. A DEM model of two active pharmaceutical ingredient (API) components and a combined excipient component was calibrated by matching the simulated response in a dynamic angle of...
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Embracing continuous manufacturing in the pharmaceutical industry
03 Jun 2024 | Website | Contributor(s): Joelle Anselmo
"Drugmakers have been slow to adopt the production process, which experts say can streamline operations, boost data quality and reduce time to market."
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A modified Kushner-Moore approach to characterising small-scale blender performance impact on tablet compaction
03 Jun 2024 | Peer-reviewed journal | Contributor(s): Hikaru G. Jolliffe, Martin Prostredny, Carlota Mendez Torrecillas, Ecaterina Bordos, Collette Tierney, Ebenezer Ojo, Richard Elkes, Gavin Reynolds, Yunfei Li Song, Bernhard Meir, Sara Fathollahi, John Robertson
Continuous Direct Compaction (CDC) has emerged as a promising route towards producing solid dosage forms while reducing material, development time and energy consumption. Understanding the response of powder processing unit operations, especially blenders, is crucial. There is a substantial body...
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Innovation and Continuous Improvement in Pharmaceutical Manufacturing
28 Mar 2024 | Document | Contributor(s): Ajaz Hussain (Chairperson) Raafat Fahmy (CVM), William Bargo (CVM), Robert Coleman, Robert (ORA), Elise Murphy (ORA), Frank Holcombe Jr (CDER), Chris Watts (CDER), See Lam (CDER), Jon Clark (CDER), Christopher Joneckis (CBER), John Dietrick (CDER), Diana Kolaitis (ORA), Vilayat Sayeed (CDER), Mai Huynh (CVM), Norman Schmuff (CDER), Andrew Chang (CBER)
The PAT Team and Manufacturing Science Working Group Report: A Summary of Learning, Contributions and Proposed Next Steps for Moving towards the "Desired State" of Pharmaceutical Manufacturing in the 21st Century
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A Shared Vision for Pharmaceutical Development and Manufacturing in the 21st Century: Contributions of the PAT Initiative
28 Mar 2024 | Document | Contributor(s): Ajaz S. Hussain
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Influence of refilling on dosing accuracy of loss-in-weight powder feeders in continuous manufacturing
19 Feb 2024 | Peer-reviewed journal | Contributor(s): Jochen Thies, Peter Kleinebudde, Fabiola N. Santamaría Alvarez
Continuous manufacturing is a novel concept to produce high quality drug products. The manufacture of solid dosage forms starts with the feeding of materials, which is consider a critical step because it could have a high influence on the quality of the final product. Therefore, this unit...
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Quality & Regulatory Solutions for PAT in Continuous Manufacturing
04 Jan 2024 | Magazine | 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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MOOC I Blending - Flow and Mixing Regime
29 Nov 2023 | Teaching Materials | Contributor(s): RCPE
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MOOC I Feeding - Refill Strategy
29 Nov 2023 | Teaching Materials | Contributor(s): RCPE
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MOOC I Blending Basics
29 Nov 2023 | Teaching Materials | Contributor(s): RCPE
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MOOC I Continuous Blender Types
29 Nov 2023 | Teaching Materials | Contributor(s): RCPE
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MOOC I Feeding - Twin Screw Feeder
29 Nov 2023 | Teaching Materials | Contributor(s): RCPE
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MOOC I Feeding - Disturbances
29 Nov 2023 | Teaching Materials | Contributor(s): RCPE
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MOOC I Continuous Blend Analysis
29 Nov 2023 | Teaching Materials | Contributor(s): RCPE
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Continuous Manufacturing to Improve Pharmaceutical Quality: Research Examples and Opportunities
20 Nov 2023 | Workshop | 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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Pharmaceutical Continuous Manufacturing: A Guide to Control Strategies for Solid Oral Dose Drugs
23 Aug 2023 | Technical Guides | Contributor(s): Atul Dubey
Advanced manufacturing technologies like pharmaceutical continuous manufacturing (PCM) can provide potential efficiencies for many medicines and their ingredients, thereby facilitating geographic diversity in manufacturing and supply chain resilience. One of the ways the U.S. Pharmacopeia (USP)...
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The Regulatory Landscape Regarding Continuous Manufacturing
17 Aug 2023 | Document | Contributor(s): Adam Fisher
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Mitigating Regulatory Challenges to Adoption of Advanced Manufacturing
17 Aug 2023 | Document | Contributor(s): Riley C. Myers
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Wet Granulation in a Twin-Screw Extruder: Implications of Screw Design
09 Jun 2023 | Peer-reviewed journal | Contributor(s): Thompson, M. R., Sun, J.
Wet granulation in twin-screw extrusion machinery is an attractive technology for the continuous processing of pharmaceuticals. The performance of this machinery is integrally tied to its screw design yet little fundamental knowledge exists in this emerging field for granulation to intelligently...