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Recombinant bacterial endotoxin testing techniques shown to be inferior
An evaluation comparing Limulus amebocyte lysate to recombinant alternative assays has found that the recombinant reagents had markedly low recovery of endotoxin activity.
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European Pharmacopoeia (Ph. Eur.)
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Pharmaceutical sterility testing market to value over $1000 million by 2027
Reports suggest the global sterility testing market will grow because of the expansion of pharma and biopharma, increasing R&D activities and the launch of new products.
news
European Pharmacopoeia publishes new chapter regarding BET testing
The new chapter describes a method for bacterial endotoxins (BET) testing using recombinant factor C (rFC) instead of limulus amoebocyte lysate (LAL).
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EDQM to provide COVID-19 vaccine developers free access to quality standards
The EDQM and European Pharmacopoeia have decided to share Ph. Eur. quality standards for COVID-19 vaccine developers to support their research.
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Lonza and Sanquin partner for commercialisation of specialised MAT reagents for accurate and reliable in vitro pyrogen testing
Lonza Sales AG, through its Bioscience Division has joined forces with Sanquin Reagents B.V. to enable drug developers and quality control laboratories to take full advantage of the power of the Monocyte Activation Test (MAT).
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A comprehensive review of the newly revised European Pharmacopoeia chapter 5.1.6
European Pharmacopoeia Chapter 5.1.6, Alternative Methods for Control of Microbiological Quality, was recently revised and published in Ph. Eur. Supplement 9.2. The new chapter comprises a number of significant changes from the original version published in 2006. Prior revisions to a similar chapter and technical report from the USP and…
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Foreword: The evolving pharmacopoeia
Globalisation has facilitated greater international harmonisation and standardisation of quality standards, which in turn has impacted on pharmacopoeias1. Historically, general chapters were developed based on input from local regions with little concern for global consequences. This often led to the development of similar, but unidentical tests, for example, Residue on…
whitepaper
Whitepaper: Feasibility of a Rapid Microbiological Method for filterable raw materials
The Milliflex® Quantum system (Merck Millipore) is a rapid method for the quantitative detection of contaminants in filterable samples...
whitepaper
Application Note: Instrumental method for quantitation of colour in drug solutions
Measurement and validation of the European Pharmacopoeia (EP) Colour scale.
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Rapid methods update: revisions to a United States Pharmacopeia chapter
3 September 2015 | By Michael J. Miller, PhD Microbiology Consultants, LLC
From 2010 to 2013, European Pharmaceutical Review published a very successful series on rapid microbiological methods (RMM) that included hot topics such as the European Medicines Agency’s and US Food and Drug Administration’s expectations, implementation strategies, scientific principles behind the technologies and validation.
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rfC included in the new draft 5.1.10 by the European Pharmacopeia
News from the European Pharmacopoeia:
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New guidelines for breakmarks on tablets
13 June 2013 | By Tony Moffat, UCL School of Pharmacy and Joint Pharmaceutical Analysis Group
The US Food and Drugs Administration (FDA) produced their guidance for industry on tablet scoring in March 2013 to ensure that tablet scoring (breakmarks or breaklines) on generic tablets would enable them to be split in the same effective way as their reference listed products (RLD).
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Hot topics in rapid methods: revisions to validation guidance and real-time environmental monitoring
18 December 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the sixth and final paper in our continuing series on Rapid Microbiological Methods (RMM) that have appeared in European Pharmaceutical Review during 2012. As many of you already know, I am keen on staying on top of recent developments in the world of rapid methods, and have used…
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Wyatt Technology MALS Fulfils Latest European Pharmacopoeia Standard for HES Characterization
24 June 2011 | By The Scott Partnership
MALS instruments represent the latest EP requirements for HES characterization....
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The implementation of rapid microbiological methods
This is the sixth and final paper in a series of articles on rapid microbiological methods that have appeared in European Pharmaceutical Review during 2010. Over the past year, we have explored the world of rapid microbiological methods (RMMs), focusing on validation strategies, regulatory expectations, and the technical and quality…
