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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...
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 .
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.
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.
This article covers how the EndoZyme II assay is established, optimised and validated using the SynergyTM HTX Multi-Mode Microplate Reader with Gen5TM software...
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.
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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)...
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...
Lonza, a world leader in biopharmaceutical development technologies, announced today the addition of two new host organisms and their associated systems to its XS Technology™ Platform. The expanded XS Technology™ Toolbox addresses the diversity of microbially-derived proteins by providing complementary expression systems that quickly deliver simple, reliable, high yielding cGMP…
