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21 February 2019 | By Hyglos-bioMerieux
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…
8 November 2018 | By Wickham Laboratories
Wickham Laboratories will be exhibiting at Pharmig’s 26th annual conference held on the 28 and 29 November at the Belfry Hotel, Nottingham...
24 October 2018 | By Associates of Cape Cod Inc
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…
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...
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