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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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Continuous manufacturing: Changing the paradigm in the pharmaceutical manufacturing sector
Magazine | 23 Sep 2024 | Contributor(s):: Indu Bhushan
The author explains how continuous manufacturing is reshaping pharmaceutical production
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The Rise of Continuous Manufacturing in Pharma
Website | 13 Aug 2024 | 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
Website | 23 Jul 2024 | 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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Embracing continuous manufacturing in the pharmaceutical industry
Website | 03 Jun 2024 | 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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Innovation and Continuous Improvement in Pharmaceutical Manufacturing
Document | 28 Mar 2024 | 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
Document | 28 Mar 2024 | Contributor(s):: Ajaz S. Hussain
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Quality & Regulatory Solutions for PAT in Continuous Manufacturing
Magazine | 04 Jan 2024 | 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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Continuous Manufacturing to Improve Pharmaceutical Quality: Research Examples and Opportunities
Workshop | 20 Nov 2023 | 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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The Regulatory Landscape Regarding Continuous Manufacturing
Document | 17 Aug 2023 | Contributor(s):: Adam Fisher
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Mitigating Regulatory Challenges to Adoption of Advanced Manufacturing
Document | 17 Aug 2023 | Contributor(s):: Riley C. Myers
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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 Changing Face of Process Development & Chemical Manufacturing - A View from the Regulators on Continuous Manufacturing
Website | 09 Jun 2023 | Contributor(s):: Wiles, Charolotte
Industry wide there is a drive for resource efficiency and flexibility, to adapt quickly in what is increasingly becoming a volatile, changing marketplace. As the ‘patent cliff’ looms for many high-volume API’s, there is also a shift away from blockbusters towards lower volume, higher potency...
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The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality - M4Q(R1)
Document | 09 Jun 2023
Guideline aims to harminze the approach to the eCTD to create efficiencies for reviewers and decrease the rejection rate for drug applications.
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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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Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Document | 09 Jun 2023
Document highlights the product lifecycle and the various considerations for maintaining consistent quality through both shelf life and entire lifecycle.
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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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Raman Spectroscopy
Document | 09 Jun 2023
Standard highlights the use of Raman spectroscopy to ensure successful application for measuring pharmaceutical products.
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Quality Risk Management
Document | 09 Jun 2023
Guideline establishes the environment surrounding risk detection and mitigation in order to maintain high quality pharmaceutical products.
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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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Powder Flow
Document | 09 Jun 2023
Standard explains the intricacies of powder flow.
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Pharmaceutical Quality System
Document | 09 Jun 2023
Guideline acts as a combination of the previous two guidelines (Q8 and Q9), giving vontext to the concepts. A Pharmaceutical Quality System is explained for practical application across all manufacturing platforms in an effort to maintain quality.
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Points to Consider: ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation
Document | 09 Jun 2023
Note highlgihts major components of three ICH guidelines (Q8, Q9, Q10), demonstrating their reliance on one another in order to be successfully applied across pharmaceutical manufacturing operations.