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10 July 2018 | By SUEZ
The United States Pharmacopeia and National Formulary (USP-NF) has been the official compendia under the United States Food and Drug Administration (FDA) since the Pure Food and Drug Act of 1906...
26 April 2018 | By Kevin L Williams - bioMerieux
Limulus amebocyte lysate (LAL) users, compendial experts and regulators are still orienting themselves to the recombinant factor C (rFC) assay. Changes to compendial standards do not occur overnight and, for now, users willing to change must perform the alternative validation procedure USP .
26 April 2018 | By Johannes Reich, Josh Eaton, Marsha Steed
Pyrogen testing of drug products for parenteral administration is a mandatory task. Regulatory authorities require that each batch of drug product is pyrogen-free. Historically, the rabbit pyrogen test (RPT) was the required test but in most cases can be replaced by the endotoxin specifi c Limulus Amebocyte Lysate (LAL) test.
13 April 2018 | By European Pharmaceutical Review
In this In-Depth Focus; specificity in the recombinant factor C test for endotoxin, the latest trends in pharmaceutical microbiology, and the changing environment in pyrogen and endotoxin testing.
13 December 2017 | By Hyglos
This article covers how the EndoZyme II assay is established, optimised and validated using the SynergyTM HTX Multi-Mode Microplate Reader with Gen5TM software...
19 October 2017 | By European Pharmaceutical Review
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.
5 July 2017 | By Charles River
A comprehensive portfolio of leading products and services...
3 July 2017 | By Associates of Cape Cod Inc
A leader in endotoxin detection for over 40 years...
15 April 2017 | By Kevin L Williams (Hyglos GmbH a BioMerieux company)
Presented here are recommendations for performing an endotoxin masking hold-time study. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have requested hold-time studies to determine the presence of what has been called ‘low endotoxin recovery’ (LER) for submission with biologic licence applications (BLA)...
13 April 2017 | By European Pharmaceutical Review
In this Microbiology In-Depth Focus: Endotoxin masking hold-time study performance parameters; Microbiological monitoring pharmaceutical water systems; The rush to rapid microbiological methods - or not; and an expert view with Charles River Laboratories...
23 December 2014 | By Dr Tim Sandle, Bio Products Laboratory
This article surveys some of the recent developments in regulatory requirements and standards that have taken place during the past 12 months, highlighting those aspects that are of relevance to pharmaceutical microbiology...
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