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An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US
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...
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The role of digital twins in driving sustainability
Peer-reviewed journal | 29 Oct 2024 | 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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Why We Need Continuous Pharmaceutical Manufacturing and How to Make It Happen
Peer-reviewed journal | 09 Jun 2023 | 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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The Current Scientific and Regulatory Landscape in Advancing Integrated Continuous Biopharmaceutical Manufacturing
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Adam C Fisher, Mark-Henry Kamga, Cyrus Agarabi, Kurt Brorson, Sau L Lee, Seongkyu Yoon
There is a trend across the pharmaceutical sector toward process intensification and continuous manufacturing to produce small-molecule drugs or biotechnology products. For biotechnology products, advancing the manufacturing technology behind upstream and downstream processes has the potential to...
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Recent progress in continuous manufacturing of oral solid dosage forms
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Vanhoorne, Valérie, Vervaet, Chris
Continuous drug product manufacturing is slowly being implemented in the pharmaceutical industry. Although the benefits related to the quality and cost of continuous manufacturing are widely recognized, several challenges hampered the widespread introduction of continuous manufacturing of drug...
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Regulatory and Quality Considerations for Continuous Manufacturing
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Allison, Gretchen, Cain, Yanxi Tan, Cooney, Charles, Garcia, Tom, Bizjak, Tara Gooen, Holte, Oyvind, Jagota, Nirdosh, Komas, Bekki, Korakianiti, Evdokia, Kourti, Dora, Madurawe, Rapti, Morefield, Elaine, Montgomery, Frank, Randolph, William, Robert, Jean-Louis, Rudd, Dave, Nasr, Moheb, Zezza, Diane
This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including...
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Process Control of Drug Product Continuous Manufacturing Operations - a Study in Operational Simplification and Continuous Improvement
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Medendorp, Joseph, Shapally, Sreendhar, Vrieze, Derek, Tolton, Kelly
Purpose The purpose of this manuscript is to demonstrate that implementation of gravimetric measurements provides the same assurance of product quality and process control as spectroscopic measurements (1) for control of drug content in a fixed-dose combination (FDC) tablet and (2) for...
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Integrated continuous manufacturing in pharmaceutical industry: current eolutionary steps toward revolutionary future
Peer-reviewed journal | 09 Jun 2023 | 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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In Vitro Performance Tests for Continuous Manufacturing: The Impact on the Current Compendial Framework from the Viewpoint of the USP New Advancements in Product Performance Testing Expert
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Li, Hanlin Li, Nir, Ishai, Hermans, Andre, Fahmy, Raafat, Lu, Xujin, Biba, Edmond, Coutant, Carrie A.
As continuous manufacturing (CM) evolves from an emerging to widely adopted technology by industry in drug productmanufacturing, the compendiaI framework in product performance testing is also being evaluated for its applicability inCM. As such, the CM Working Group of the New Advancements in...
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Global Regulatory Landscape
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Matsuda, Y
Continuous manufacturing (CM) of pharmaceuticals is a rapidly growing approach in the production of active pharmaceutical ingredients and finished products. The European Medicines Agency, the US Food and Drug Administration, and the Pharmaceuticals and Medical Devices Agency have independently...
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Future Supply Chains Enabled by Continuous Processing - Opportunities and Challenges
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Jagjit Singh Srai, Markus Krumme, Mauricio Futran, Clive Badman, Craig Johnston
This paper examines the opportunities and challenges facing the pharmaceutical industry in moving to a primarily “continuous processing”-based supply chain. The current predominantly “large batch” and centralized manufacturing system designed for the “blockbuster” drug has driven a slow-paced,...
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Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Mohammed Maniruzzaman, Ali Nokhodchi
Over recent decades, HME techniques have appeared as an innovative manufacturing platform for various pharmaceutical applications. HME has been successfully applied to develop multiple drug delivery systems for various applications (e.g., solubility enhancement, sustained release, taste masking,...
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Continuous manufacturing – the Green Chemistry promise?
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Klavs F. Jensen
Continuous manufacturing and Green Chemistry, are two promising approaches to synthesis with underutilized potential that are gaining traction by the wider pharmaceutical community. We review Green Chemistry advances resulting when transitioning to continuous manufacturing with focus on Green...
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Adequacy and Verifiability of Pharmaceutical Mixtures and Dose Units by Variographic Analysis (Theory of Sampling) - A Call for a Regulatory Paradigm Shift
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Esbensen, Kim H, Román-Ospino, Andrés D., Sanchez, Adriluz, Romañach, Rodolfo J.
In spite of intense efforts in the last 20 years, the current state of affairs regarding evaluation of adequacy of pharmaceutical mixing is at an impressive standstill, characterized by two draft guidances, one withdrawn, and the other never approved. We here analyze the regulatory, scientific...
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Achieving Continuous Manufacturing for Final Dosage Formation: Challenges and How to Meet Them
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Byrn, Stephen, Futran, Maricio, Thomas, Hayden, Jayjock, Eric, Maron, Nicola, Meyer, Robert F., Myerson, Allan S., Thien, Michael P., Trout, Bernhardt L.
We describe the key issues and possibilities for continuous final dosage formation, otherwise known as downstream processing or drug product manufacturing. A distinction is made between heterogeneous processing and homogeneous processing, the latter of which is expected to add more value to...
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A perspective on Quality-by-Control (QbC) in pharmaceutical continuous manufacturing
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Su, Qinglin, Ganesh, Sudarshan Moreno, Mariana Bommireddy, Yasasvi, Gonzalez, Marcial, Reklaitis, Gintaras V., Nagy, Zoltan K.
The Quality-by-Design (QbD) guidance issued by the US Food and Drug Administration (FDA) has catalyzed the modernization of pharmaceutical manufacturing practices including the adoption of continuous manufacturing. Active process control was highlighted recently as a means to improve the QbD...