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Ph. Eur. rabbit pyrogen test replacement texts ready for public consultation
The rabbit pyrogen test replacement texts in Pharmeuropa 35.1 by the European Pharmacopoeia have been published for public comment.
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Endotoxin Detection
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Endotoxin trends: sustainability, automation and beyond
In this Q&A Miriam Guest, Principal Microbiologist at AstraZeneca UK, discusses trends in bacterial endotoxin testing, as well as factors to consider when looking to implement rapid methods.
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European Pharmaceutical Review Issue 1 2023
EPR Issue 1 includes articles on the future of pharmaceutical microbiology, separation and purification of complex biologics, the latest on nitrosamines and more...
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Peracetic acid-UV light treatment could improve microbial water quality
Researchers have shown a combination of peracetic acid and ultraviolet light could improve microbial water quality in pharmaceutical water systems.
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Whitepaper: Futurising the QC lab with automated endotoxin testing
Nicola Reid, Associate Director of Product Management, Microbial Solutions, Charles River looks at implementing robotic endotoxin testing for throughput optimisation and human error reduction.
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Pharma’s green mission: trends in bacterial endotoxin testing
Having recently conducted a project to implement more sustainable, reliable and efficient bacterial endotoxin testing across the global Roche corporation, those involved in the project discuss with EPR’s Hannah Balfour the key takeaways from their implementation and validation, as well as current trends in bacterial endotoxin testing.
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Your endotoxin experts
A new age of sustainability: discover how ACC’s PyroSmart NextGen® recombinant Cascade Reagent (rCR) enhances bacterial endotoxin testing (BET).
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An Annex 1 and Pharma 4.0 perspective on water quality
Pharma 4.0 is coming and is further driven by the recent update of the EU GMP Annex 1 regarding manufacturing of sterile medical products, setting new regulatory expectations in all manufacturing processes. Here, Isabella Jul-Jørgensen from the University of Denmark focuses on sterile water quality and how the new requirements…
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Microbiology In-Depth Focus 2022
Features in this in-depth focus review the advances in bacterial genome sequencing and its role in pharmaceutical microbiology, as well as key considerations for when implementing and validating recombinant Factor C (rFC) endotoxin testing. Plus, coverage of how proposed US pharmaceutical regulation could impact European companies, in-house lentiviral vector manufacturing…
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Product hub: How can CGT manufacturers ensure product safety with Microbial Solutions QC test methods?
Innovation forms the basis of every emerging technology. That is certainly the case with cell and gene therapies (CGTs), and the search for efficient quality control (QC) test methods continues to grow in this pharmaceutical sector. One of the most important factors to consider while deciding on a QC method…
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A strategic approach to optimisations of testing bacterial endotoxins
Given industry's recent focus on the sustainability of bacterial endotoxin testing (BET), here, AstraZeneca colleagues Miriam Guest, Karen Capper, Dennis Wong and Phil Duncanson share how they worked to establish a short-, mid- and long-term strategy to optimise BET across the global enterprise. They also explore some of the short-term…
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Environmental Monitoring In-Depth Focus 2022
Features in this in-depth focus explore the development of a sustainable approach to bacterial endotoxin testing (BET) within a global enterprise, as well as progress towards the use of biofluorescent particle counters for water bioburden applications.
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European Pharmaceutical Review Issue 4 2022
In EPR Issue 4, experts discuss implementing a global strategy to improve the sustainability of endotoxin testing, how to accelerate timelines for manufacture of multi-specific antibodies and the potential of oncolytic viruses as a therapy for glioblastoma. Also featured: progress towards smart vaccine manufacturing, an update on edible anticounterfeiting technology,…
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Lonza’s latest: More sensitive non-endotoxin pyrogen detection now possible with Lonza’s new PyroCell® Monocyte Activation Test – Human Serum System
The PyroCell® Monocyte Activation Test - Human Serum System (PyroCell® MAT HS System) provides more sensitive detection of non-endotoxin pyrogen contaminants in pharmaceutical preparations.
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Quality-driven solutions from discovery to commercialisation
Find out how SGS’s high-quality analytical testing solutions could benefit all phases of your drug development programmes, from discovery through commercialisation.
