List view / Grid view
Wickham Laboratories Ltd, backed by five decades of global experience in GMP/GLP-regulated laboratory services, is an established name in the fields of pharmaceutical and medical device contract testing, research and consultancy.
The work of a pharmaceutical scientist requires precision, attention to detail and is of vital importance to the safety of products and ultimately patients. This section features insights from experienced scientists who’ve worked extensively in microbiological analysis, developing tests, methods and standards that help establish a foundation for the production…
Emerging recombinant Factor C (rFC) methods have many advantages to offer pharmaceutical quality control, including improved specificity, robustness, efficiency and alignment with 3R principles. First, global manufacturers have validated rFC and pharmacopoeias worldwide are on the move. Here, Karolina Heed provides an industry and regulatory update.
Microplate-based standard endotoxin tests require time-consuming manual handling steps, the results of which are by no means conclusive. Read how the GO PLATE - part of ENDOZYME II GO - helps to address these issues.
In this edition of our ‘Guide to’ series, learn how these leading companies’ services and expertise can help you test your pharma/ biopharma products and medical devices.
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…
In this edition, five leading testing service providers explain how they cater for the pharmaceutical industry’s changing needs.
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.
A leader in endotoxin detection for over 40 years...
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 Issue #3 2017: In-Depth Focuses covering Raman Spectroscopy, Separations & Purifications, Formulation Development & Delivery; Guide To Testing Services; GMP and mutual recognition; Regulatory Insight; RMMs; Microbiology Series; and much more...
In an interview with European Pharmaceutical Review, Gilles Goy, Operational Manager of the European Endotoxin and Microbial Detection Contract Staff Laboratory, Charles River, discusses the company’s Accugenix® AccuPRO-ID® service...
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...
Alan Hoffmeister, Global Field Technical Manager for the Endotoxin and Microbial Detection Division, Charles River, discusses the Endosafe®-Nexus™...
Lonza Walkersville, Inc. and Hyglos GmbH, a German biotech company, announced today that they have reached a mutually beneficial global settlement which includes a license agreement for Hyglos under certain Lonza patents in the area of endotoxin detection.
