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This issue questions whether companies are sufficiently investing in regulatory intelligence software and what the potential consequences of Brexit might be for locations outside of the UK and EU. The issue also features articles on microbiology, formulation and biopharma, courtesy of our in-depth focus sections; as well as outlining the…
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…
Wickham Laboratories will be exhibiting at Pharmig’s 26th annual conference held on the 28 and 29 November at the Belfry Hotel, Nottingham...
Specialising in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a leader in endotoxin detection products and services for nearly 45 years. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents; ACC has grown to be an internationally…
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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A leader in endotoxin detection for over 40 years...
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...
