All Continuous manufacturing and PAT articles – Page 3
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NewsRegulatory revision essential for bioprocess IIoT adoption
A limited number of Industrial Internet of Things (IIoT) applications exist in the bioprocessing industry and remain to be challenged in manufacturing operations, research has highlighted.
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ArticleThe nitty gritty of biotherapeutics production
Caroline Peachey chats with Mahesh Bhalgat, COO at Syngene International Limited about the role of new technology in biotherapeutics production.
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ArticleNitrosamines analysis with LC/MS-MS
This ebook provides a comprehensive overview of nitrosamine analysis for the pharmaceutical industry.
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ArticleEmbracing automation in sterile manufacturing
Krishna Venkatesh, Global Head Sterile Operations at Dr Reddy's Laboratories discusses how and why the pharma industry is embracing automation.
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Article
Elevating pharmaceutical manufacturing processes with real-time insights
(Bio)pharmaceutical manufacturing is changing considerably, with key innovations enabling companies to rethink R&D, manufacturing, quality control and quality assurance (QC/QA) operations. The spotlight is squarely on process analytical technology (PAT), which underpins the successful transition towards highly effective advanced manufacturing strategies. Martin Gadsby, Chairman of Optimal Industrial Technologies, looks at ...
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OpinionDigitalisation and PAT: current landscape and future trends
In this exclusive interview from CPHI 2023, Mohamed Noor, Digitalization Manager at the National Institute for Bioprocessing Research and Training (NIBRT), explores the trends, challenges and opportunities that digitalisation and process analytical technology (PAT) have within the biopharmaceutical industry.
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NewsChromatography technique developed as continuous on-line PAT tool
The widely used continuous chromatography technique, simulated moving bed (SMB) chromatography, developed to the micro-scale as a process analytical technology (PAT) application, has been shown to greatly increase mass spectrometry sensitivity.
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ArticleEuropean Pharmaceutical Review Issue 5 2023
EPR Issue 5 includes articles on microbiological testing of ATMPs, the use of inline Raman spectroscopy for bioprocess control, paediatric drug formulation, and more.
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VideoVideo: Ami Polymer: Setting new bioprocessing standard
Our dedication to quality and prompt service has earned us several awards. You can trust us for top-notch service and reliability.
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Webinar
RMMs and endotoxin testing: efficiency gains and regulatory perspectives
Learn how Rapid Microbiological Methods can provide results in less than 45 minutes and endotoxin assays can be set up in less than 10 minutes to improve contamination control and reduce risk.
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ArticleUncovering new frontiers in microbiology and EM
In this Q&A, Laure Pomares Voisin, Quality Director, Catalent Biologics and Tony Cundell Principal Consultant, Microbiological Consulting, LLC discuss some of the key microbiology and environmental monitoring challenges and trends in pharmaceutical manufacturing today.
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NewsPioneering PAT to improve gene therapy AAV manufacture
The CGT Catapult and two other collaborators have agreed to work together and use advanced process analytical technologies (PAT) to improve the process and efficiency of gene therapy AAV manufacturing.
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Whitepaper
Technical document: Introducing: Ami Polymer's Sterile Sampling Systems
Next-Gen Sterile Sampling System: Pinnacle Compliance - USP Standards 87, 88, 85, 661.1, 788, 71, and ISO 11737-1 for Unparalleled Pharma & Biopharma
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ArticleLeveraging PAT for environmental monitoring in light of Annex 1
The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which entered into force in August. Here, Isabella Jul-Jørgensen from ...
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NewsMiniaturised PAT tool demonstrates real-time aggregation measurement
Researchers have described how a process analytical technologies (PAT) fluorescent dye (FD)-based microfluidic sensor facilitated immediate feedback and control of process parameters for continuous downstream processing.
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Whitepaper
Whitepaper: Sustainable microbial monitoring
This white paper looks at the environmental impact of plate count testing and how on-line microbial detection supports sustainable pharma manufacturing.
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NewsUK medicines manufacturing to get innovation boost
A multi-million investment is set to enhance UK medicines manufacturing in three key areas: intracellular drug delivery, digitalisation and automation and nucleic acid medicines.
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Webinar
Implementing continuous flow technologies in commercial manufacturing
Watch this webinar to hear Ajinomoto Bio-Pharma Services discuss how continuous flow manufacturing can support the capable handling of dangerous chemicals, which is crucial for the manufacture of safe products.
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NewsAccelerating biomanufacturing with automated PAT systems
Experts at Amgen have highlighted a micro sequential injection (µSI) process analyser and automatic assay preparation platform (A2P2) as an autonomous process analytical technology (PAT) platform to enable rapid testing and release of biopharmaceutical products.
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ArticleDigitalising HPLC methods: the path to interoperability
Transferring analytical methods between companies is often a challenging, time-consuming manual process. In this Q&A, Dr Birthe Nielsen, Project Lead at The Pistoia Alliance, speaks about an ongoing project to digitally transfer HPLC data between different vendors.
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