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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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BioIVT Acquires Optivia Biotechnology, Adding Transporter Assay Products and Services to its ADME-Tox Portfolio
BioIVT,
a leading provider of research models and services for drug development, today
announced that it has acquired Santa Clara, CA-based Optivia Biotechnology and
its comprehensive portfolio of transporter assays, multi-transporter models,
transporter systems biology, and molecular transport research solutions.
More info >> |
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White Papers |
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Migration safe pharmaceutical labels improve patient safety
UPM Raflatac
Labels play an invaluable role on pharmaceutical packages. Pharmaceutical companies should only use labels that meet low-leachability and extraction requirements. Labels that are not migration safe, e.g. create leachable chemical compounds, may fail testing and result in significant launch delays or costly recalls. This white paper presents how pharmaceutical companies can ensure that the final label constructions achieve their business, regulatory and patient safety goals.
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Industry Events |
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Outsourcing Clinical Trials Nordics 2018
30-31 October 2018, Copenhagen, Denmark
Following on from the success of the 2017 Outsourcing in
Clinical Trials Nordics conference, Arena International is pleased to announce
that the event will return for its 6th year in 2018.
The 2018 event welcomes biopharmaceutical and medical device
companies from across the Nordic region to share knowledge and challenges of
outsourcing and clinical operations.
More info >> |
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