Peer-reviewed journal feed

1. An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US

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   Peer-reviewed journal | 20 Nov 2024 | Contributor(s):: Adam C. Fisher, William Liu, Andreas Schick, Mahesh Ramanadham, Sharmista Chatterjee, Raphael Brykman, Sau L. Lee, Steven Kozlowski, Ashley B. Boam, Stelios C. Tsinontides, Michael Kopcha

   Continuous manufacturing (CM) sends materials directly and continuously to the next step of a process, eliminating hold times and reducing processing times. The potential benefits of CM include improved product quality, reduced waste, lower costs, and increased manufacturing flexibility and...

2. Development and process scaling of repeat mini-blending as a complementary approach to deliver continuous direct compression

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   Peer-reviewed journal | 13 Nov 2024 | Contributor(s):: Martin Prostredny, Hikaru Graeme Jolliffe, Richard Elkes, Khalid Maqsood, Yunfei Li Song, Gavin Reynolds, Bernhard Meir, John Robertson

   Process integration efforts in the pharmaceutical industry have led to an increased interest in Direct Compression, including Continuous Direct Compression. Accurate scale-up of powder blending and prediction of blend Critical Quality Attributes (CQAs) is key. The present work takes a modified...

3. Demonstrating scalability between two blender types using DEM

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   Peer-reviewed journal | 12 Nov 2024 | Contributor(s):: Peter Boehling, Johan Remmelgas, Mohammadsadegh Salehi, Johannes Poms, Rúben Martins Fraga, Manel Bautista, Johannes G. Khinast, Emmanuela Gavi, Michela Beretta

   Powder blending is a critical step in pharmaceutical manufacturing that can impact product quality such as tablet tensile strength. This study utilized the Discrete Element Method (DEM) to investigate blending in a 5-liter mini-batch and a 2-liter Turbula blender. DEM parameters were calibrated...