All Endotoxin Detection articles – Page 2
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NewsNovel strategy could facilitate rapid online-endotoxin monitoring
An innovative, chemosensor-based method for detection of lipopolysaccharide (LPS) is set to facilitate development of a rapid online-endotoxin monitor.
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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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NewsProposed non-animal derived reagent Chapter published
USP’s proposed new Chapter , which offers additional information on Bacterial Endotoxins Tests (BETs) using non-animal derived reagents, has been published as a General Announcement in advance of public consultation.
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NewsDetermining accurate estimation of true endotoxin concentration
Research suggests that performing LAL gel clot tests and narrowing the dilution range can provide good estimation of endotoxin concentration in pharmaceuticals.
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NewsWhy is microbiological testing in medical device manufacturing important?
Careful planning during manufacture means accurate microbiology testing methods can be developed, ensuring the safety and efficacy of medical devices, a paper reports.
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ArticleGuide To Testing
In this edition, experts from Institute of Biomedical Research Antoine Marxer and Associates of Cape Cod International share insight on endotoxin testing.
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ArticleEuropean Pharmaceutical Review Issue 2 2023
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
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NewsPh. 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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Article
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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ArticleEuropean 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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NewsPeracetic 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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