-
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.
-
Continuous manufacturing: Changing the paradigm in the pharmaceutical manufacturing sector
23 Sep 2024 | Magazine | Contributor(s): Indu Bhushan
The author explains how continuous manufacturing is reshaping pharmaceutical production
-
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...
-
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...
-
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."
-
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
-
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
-
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...
-
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 -...
-
The Regulatory Landscape Regarding Continuous Manufacturing
17 Aug 2023 | Document | Contributor(s): Adam Fisher
-
Mitigating Regulatory Challenges to Adoption of Advanced Manufacturing
17 Aug 2023 | Document | Contributor(s): Riley C. Myers
-
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.
-
The Changing Face of Process Development & Chemical Manufacturing - A View from the Regulators on Continuous Manufacturing
09 Jun 2023 | Website | 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...
-
The Current Scientific and Regulatory Landscape in Advancing Integrated Continuous Biopharmaceutical Manufacturing
09 Jun 2023 | Peer-reviewed journal | 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...
-
The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality - M4Q(R1)
09 Jun 2023 | Document
Guideline aims to harminze the approach to the eCTD to create efficiencies for reviewers and decrease the rejection rate for drug applications.
-
Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
09 Jun 2023 | Document
Document highlights the product lifecycle and the various considerations for maintaining consistent quality through both shelf life and entire lifecycle.
-
Recent progress in continuous manufacturing of oral solid dosage forms
09 Jun 2023 | Peer-reviewed journal | 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...
-
Regulatory and Quality Considerations for Continuous Manufacturing
09 Jun 2023 | Peer-reviewed journal | 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...
-
Raman Spectroscopy
09 Jun 2023 | Document
Standard highlights the use of Raman spectroscopy to ensure successful application for measuring pharmaceutical products.
-
Quality Risk Management
09 Jun 2023 | Document
Guideline establishes the environment surrounding risk detection and mitigation in order to maintain high quality pharmaceutical products.
-
Process Control of Drug Product Continuous Manufacturing Operations - a Study in Operational Simplification and Continuous Improvement
09 Jun 2023 | Peer-reviewed journal | 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...
-
Powder Flow
09 Jun 2023 | Document
Standard explains the intricacies of powder flow.
-
Pharmaceutical Quality System
09 Jun 2023 | Document
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.
-
Points to Consider: ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation
09 Jun 2023 | Document
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.
-
Powder Fineness
09 Jun 2023 | Document
Standard reviews the properties of powder including fineness, providing important information for continuous manufacturing as powder is required to continuously flow through the system.