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This article covers the analytical criteria that apply to Bacterial Endotoxin Testing (BET) using Limulus Amebocyte Lysate (LAL) or recombinant Horseshoe crab Factor C (rFC) for the bioactivity determination of endotoxin in aqueous solutions, such as pharmaceuticals and medical device extracts. It explains the importance of these criteria for accurate…
The contamination of pharmaceuticals by microorganisms represents a major threat to public health, not just in the USA and Europe, but all around the world. Pathogenic microorganisms cause morbidity and in some cases mortality when present in products.1,2 Spoilage due to microbial breakdown of formulations can affect potency and shelf…
The Burkholderia cepacia complex (BCC) species are a group of gram-negative, rod-shaped bacteria that have been shown in recent years to be of concern for patients, and thus for manufacturers of drugs and products that contribute to patient health...
Maintaining the long-term safety of a manufacturing environment while meeting the demands of compliance is a microbial quality control manager’s top priority...
Large-scale downstream processing of viruses for clinical applications poses challenges different from those for many other biotherapeutics...
Researchers create a device that allows more electron beam to pass through liquid samples...
The FDA has authorised the first test to identify the emerging pathogen Candida auris, which can cause serious infections in hospitalised patients...
Microbiological contamination of non-sterile medicinal products is an infrequent, but longstanding and recurring issue. But there is no ‘one size fits all’ approach towards objectionable organisms, says David Elder...
The European Pharmacopoeia chapter on methods for microbiological quality control was recently revised to include a number of significant changes. In this In-Depth Focus Michael Miller provides the first part of this two-part review and Kevin Williams discusses a paradigm change in biologics microbiological contaminant control.
An effective environmental monitoring programme is designed to estimate the microbial content of the room’s air and surfaces (by incident rate, against alert and action levels, and by assessment of different species) for operations performed within a cleanroom or controlled environment.
A comprehensive portfolio of leading products and services...
This scientific poster reviews numerous scientific literature related to microbial survival under a broad range of environmental pressure conditions, and the resilience of microorganisms under variable compression and decompression environments.
Welcome to European Pharmaceutical Review’s Guide to Testing Services, the second in our new series of ‘Guide to …’ supplements. In this edition, five leading testing service suppliers explain how their service offering meets current industry needs...
In this supplement, we've brought together a collection of interesting posters from leading companies in order to celebrate cutting-edge research in the pharmaceutical industry and to share with our readers some of the varied work being carried out by their colleagues...
Over the last decade, research has revealed more about the human gut microbiome—the environment within the gastrointestinal tract—where microbes, especially bacteria, reside.
