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| home > white papers > Life Cycle of an Analytical Method - a Case Study on the Monocyte Activation Test - Wickham Laboratories Limited |
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 WHITE PAPERS |
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Wickham Laboratories Limited
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Life Cycle of an Analytical Method - a Case Study on the Monocyte Activation Test
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Pyrogens, a heterogeneous group of fever inducing contaminants, are comprised of microbial and non-microbial compounds; e.g. endotoxin (lipopolysaccharide, LPS) produced by Gram-negative bacteria, lipoteichoic acid (LTA) from Gram-positive bacteria, bacterial DNA (CpG-motive), endogenous pyrogens, virus and fungi particles or even fragments of packaging materials, plastic and dust. Contaminat ion wi th pyrogens in pharmaceutical products, biotherapeutics and on medical devices can lead to life threatening fever reactions. To ensure consumer safety, pyrogen testing is mandatory for parenteral products and medical devices.
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News and Press Releases |
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NDA Group Releases Data Comparing FDA and EMA Ahead of Annual DIA Europe in Basel
Today NDA Group announced their findings from its fifth annual
comparison of drug approvals in Europe and the United States, in
preparation for this year’s DIA Europe in Basel, Switzerland. The
figures highlight the continued differences between the two regions, and
the need for a global approach to drug development to ensure success
across both continents.
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White Papers |
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New Temperature Profiles from a Global Study
Laminar Medica
Recently there has been an influx of temperature
mapping studies to collect sufficient ambient data to develop temperature
profiles. Solid temperature profiles on
specific shipping routes are required to ensure streamlined packaging and robust
lane qualification.
The most reliable method to develop
temperature profiles is to capture the actual reading from shipments, as well
as using the historical and meteorological data to increase the confidence
level.
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Industry Events |
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3rd Annual Inhalation & Respiratory Drug Delivery Congress
8-9 May 2018, London, UK
Oxford Global are proud to present our hugely
popular 3rd Annual Inhalation & Respiratory Drug Delivery Congress, 8th –
9th May 2018, London, UK. Over 300 delegates representing
global pharmaceutical organisations, leading biotech companies and
internationally renowned academic institutions will gather for over 20
presentations and case studies focused on the key issues in inhalation and
respiratory drug delivery.
More info >> |
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