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The role of digital twins in driving sustainability
29 Oct 2024 | Peer-reviewed journal | Contributor(s): Deborah McElhone, Barrie Cassey, Kamal Abu-Hassan
As the pharmaceutical sector endeavours to become more sustainable, we hear how digital twins – virtual replicas of systems or products that can help predict performance – are supporting the industry in its efforts.
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A modeling and control framework for extraction processes
05 Sep 2024 | Peer-reviewed journal | Contributor(s): Peter Neugebauer, Jakob Rehrl, Peter Poechlauer, Dirk Kirschneck, Martin Horn, Martin Steinberger, Stephan Sacher, Joscha Boehm, Daniel Moser
Many continuously operated pharmaceutical process routes have been presented recently. Most of these cover the synthesis of the active pharmaceutical ingredient (API) or solid dosage processing. However, the API purification is also gaining attraction. One widespread and waste-intensive unit...
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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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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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Delta-mannitol to enable continuous twin-screw granulation of a highly dosed, poorly compactable formulation
23 Jul 2024 | Peer-reviewed journal | Contributor(s): Vanhoorne, V., Almey, R., De Beer, T., Vervaet, C.
In current study, it was investigated if the moisture-mediated polymorphic transition from δ- to β-mannitol during twin screw granulation (TSG) also took place in high drug loaded formulations and if the specific granule morphology associated with the polymorphic transition could enable tableting...
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Process Intensification via End-to-End Continuous Manufacturing of Atorvastatin Calcium Using an Integrated, Modular Reaction-Crystallization-Spherical Agglomeration-Filtration-Drying Process
23 Jul 2024 | Peer-reviewed journal | Contributor(s): Parvaresh, Rojan, Nagy, Zoltan K.
Continuous manufacturing can show potential benefits over batch processing in lower turnaround times and smaller footprint in addition to higher productivity, adaptability, and consistent product quality. Although these possible benefits exist, there are also challenges in integrating the various...
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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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Control oriented modeling of twin-screw granulation in the ConsiGmaTM-25 production plant
09 Jul 2024 | Peer-reviewed journal | Contributor(s): Johannes Khinast, Martin Horn, Jakob Rehrl, Selma Celikovic, Johannes Poms
ConsiGmaTM-25 is a continuous production plant integrating a twin-screw granulation, fluid bed drying, granule conditioning, and a tableting unit. The particle size distribution (PSD), active pharmaceutical ingredient (API) content, and liquid content of wet granules after twin-screw...
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Development and Application of Control Concepts for Twin-Screw Wet Granulation in the ConsiGmaTM-25: Part 2 Granule Size
04 Jun 2024 | Peer-reviewed journal | Contributor(s): Selma Celikovic, Johannes Poms, Johannes Khinast, Martin Horn, Jakob Rehrl
Traditional operation modes, such as running the production processes at constant process settings or within a narrow design space, do not fully exploit the advantages of continuous pharmaceutical manufacturing. Integrating Quality by Control (QbC) algorithms as a standard component of...
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Continuous Flow Intensification for the Synthesis of High-Purity Warfarin
10 May 2024 | Peer-reviewed journal | Contributor(s): Silva-Brenes, Diana V., Reyes-Vargas, Stephanie K., Duconge, Jorge, Vlaar, Cornelis, Stelzer, Torsten, Monbaliu, Jean-Christophe M.
While racemic warfarin was initially commercialized as a rodenticide, it has become the most prescribed anticoagulant drug for prevention of blood clots and is part of the World Health Organization’s list of essential medicines. The synthesis of warfarin appears straightforward, consisting of a...
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Rapid production of the anaesthetic mepivacaine through continuous, portable technology
24 Apr 2024 | Peer-reviewed journal | Contributor(s): Díaz-Kruik, Pablo, Paradisi, Francesca
Local anaesthetics such as mepivacaine are key molecules in the medical sector, so ensuring their supply chain is crucial for every health care system. Rapid production of mepivacaine from readily available commercial reagents and (non-dry) solvents under safe conditions using portable,...
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Multi-step Flow Synthesis of the Anthelmintic Drug Praziquantel
24 Apr 2024 | Peer-reviewed journal | Contributor(s): Phull, Manjinder Singh, Bohara, Chander Singh, Gundla, Rambabu, Mainkar, Prathama S., Jadav, Surender Singh
Praziquantel (PZQ; Brand name: Biltricide) is categorized as an anthelminthic drug, and it is used for the treatment of Schistosomiasis and other parasitic infections. The World Health Organization (WHO) has classified it as one of the essential and emergency medicines needed across the globe....
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Continuous Flow-Facilitated CB2 Agonist Synthesis, Part 2: Cyclization, Chlorination, and Amination
24 Apr 2024 | Peer-reviewed journal | Contributor(s): Prieschl, Michael, Sagmeister, Peter, Moessner, Christian, Sedelmeier, Joerg, Williams, Jason D., Kappe, C. Oliver
A new route to the cannabinoid receptor type 2 agonist, RG7774, has been developed circumventing an alkylation with poor regioselectivity as the final step. In the new synthetic route, this side chain is incorporated from the beginning. In this article, the development of the final four...
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A Continuous Process for Manufacturing Apremilast. Part I: Process Development and Intensification by Utilizing Flow Chemistry Principles
24 Apr 2024 | Peer-reviewed journal | Contributor(s): Hsieh, Hsiao-Wu, Griffin, Daniel J., Ananthoji, Padmini, Avci, Nadide Hazal, Brown, Derek B., Ericson, Ari, Fostinis, James D., Irfan, Muhammad, Langille, Neil, Lovette, Michael A., Murray, James I., Spada, Simone, Thiel, Oliver R., Aiello, Frankie, Daou, Joseph, Goudas-Salomon, Nicole, Pan, Ende, Sarkar, Nandini, Wimalasinghe, Rasangi, Wu, Zufan Steven, Zeng, Alicia, Beaver, Matthew G., Cohen, Carolyn M.
Herein, we report the development of an integrated continuous manufacturing (CM) process for the penultimate step in the synthesis of apremilast, the drug substance (DS) of the commercial product Otezla. This development effort was motivated by the desire to create an alternative manufacturing...
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Compact NMR Spectroscopy for Automated Continuous-Flow Production of Chemicals and Pharmaceuticals (On-Demand)
31 Jan 2024 | Seminars | Contributor(s): Klas Meyer
Chemical companies are under constant pressure to improve productivity while cutting costs. Flexible and modular chemical plants can produce high-quality products using multi-purpose equipment with short downtimes, reducing time to market for new products. Intensified continuous production...
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MOOC I Control Strategy - Process Control
29 Nov 2023 | Teaching Materials | Contributor(s): RCPE
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MOOC I Control Strategy - Examples
29 Nov 2023 | Teaching Materials | Contributor(s): RCPE
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MOOC I Control Strategy - Introduction
29 Nov 2023 | Teaching Materials | Contributor(s): RCPE
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MOOC I Control Strategy - Quality Control
29 Nov 2023 | Teaching Materials | Contributor(s): RCPE
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Videometric mass flow control: A new method for real-time measurement and feedback control of powder micro-feeding based on image analysis
09 Jun 2023 | Peer-reviewed journal | Contributor(s): Madarasz, L, Kote, AGyurkes, M, Farkas, A, Hambalko, B, Pataki, H, Fulop, G, Marosi, G, Lengyel, L, Casian, T, Csorba, K, Nagy, ZK
The present paper reports the first monitoring and control of ultra-low dose powder feeding using a camera image-based mass flow measurement system. Caffeine was fed via a single-screw microfeeder as a model active pharmaceutical ingredient (API). The mass, mass flow and sizes of the particles...
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Why We Need Continuous Pharmaceutical Manufacturing and How to Make It Happen
09 Jun 2023 | Peer-reviewed journal | Contributor(s): Clive Badman, Charles L.Cooney, Alastair Florence, Konstantin Konstantinov, Markus Krumme, Salvatore Mascia, Moheb Nasr, Bernhardt L. Trout
We make the case for why continuous pharmaceutical manufacturing is essential, what the barriers are, and how to overcome them. To overcome them, government action is needed in terms of tax incentives or regulatory incentives that affect time.
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Visualization and understanding of the granulation liquid mixing and distribution during continuous twin screw granulation using NIR chemical imaging
09 Jun 2023 | Peer-reviewed journal | Contributor(s): Vercruysse, Jurgen, Toiviainen, Maunu, Fonteyne, Margot, Helkimo, Niko, Ketolainen, Jarkko, Juuti, Mikko, Delaet, Urbain, Van Assche, Ivo, Remon, Jean Paul, Vervaet, Chris, De Beer, Thomas
Over the last decade, there has been increased interest in the application of twin screw granulation as a continuous wet granulation technique for pharmaceutical drug formulations. However, the mixing of granulation liquid and powder material during the short residence time inside the screw...
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Using residence time distribution in pharmaceutical solid dose manufacturing–A critical review
09 Jun 2023 | Peer-reviewed journal | Contributor(s): Bhalode, Pooja, Tian, Huayu Gupta, Shashwat Razavi, Sonia M Roman-Ospino, Andres Talebian, Shahrzad Singh, Ravendra Scicolone, James V Muzzio, Fernando J, Ierapetritou, Marianthi
While continuous manufacturing (CM) of pharmaceutical solid-based drug products has been shown to be advantageous for improving the product quality and process efficiency in alignment with FDA’s support of the quality-by-design paradigm (Lee, 2015; Ierapetritou et al., 2016; Plumb, 2005; Schaber,...
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Use of the channel fill level in defining a design space for twin screw wet granulation
09 Jun 2023 | Peer-reviewed journal | Contributor(s): Gorringe, L. J., Kee, G. S., Saleh, M. F., Fa, N. H., Elkes, R. G.
Twin screw wet granulation is a key process in the continuous manufacture of oral solid dosage forms. Previous Research Article has qualitatively suggested that the channel fill level influences the granules produced. In this paper a quantitative measure of the total volumetric fraction of the...
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Twin-screw melt granulation: Current progress and challenges
09 Jun 2023 | Peer-reviewed journal | Contributor(s): Kittikunakorn, Nada, Liu, Tongzhou, Zhang, Feng
Twin-screw melt granulation (TSMG) is a new alternative method for granulation that offers several advantages over wet and dry granulation methods. TSMG has rapidly gained interest over recent years in the pharmaceutical industry. Since it is an inherently continuous process with controlled...