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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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ROUSSELOT INTRODUCES X-PURE® GelMA FOR TRANSLATIONAL MEDICINE
Irving, United States [03 June 2020] — Rousselot, a Darling Ingredients brand and the global leader of collagen-based solutions, takes on the digital challenge and introduces X-Pure® GelMA at Bio Digital 2020. The first GMP-ready range of gelatin methacryloyl (GelMA) biomaterials suitable for preclinical and clinical applications, X-Pure® GelMA is part of the X-Pure portfolio of ultra-pure gelatins and collagens, suitable for use as biomaterials in 3D bioprinting, tissue engineering, and regenerative medicine.
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White Papers |
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Clinical Trial Site Contracting: The Conservative, Progressive and Hybrid Models
DrugDev
For the last 20 years, pharmaceutical companies have turned to a variety of clinical outsourcing solutions to reduce costs and improve timelines, enabling them to focus on their core value of research and development. In today’s tightly competitive market, companies are constantly striving for ways to further cut costs and reduce study startup cycle times, while maintaining quality.
One of the key cost factors in global R&D spending, estimated at around $102 billion per Kalorama market research, is the cost of conducting clinical trials. CRO’s, which account for about 30% of the total R&D spending, have risen to the challenge of the clinical, technical and administrative management of these trials. But some pharmaceutical companies question how much control to relinquish to vendor partners, especially in the legal arena, due to potential ramifications.
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Industry Events |
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12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology
8-11 February 2021, Vienna, Austria
In continuation of the very successful scientific meetings in Budapest, Paris, Berlin, Florence, Geneva, Barcelona, Malta, Istanbul, Lisbon, Glasgow and Granada, the 12th PBP World will be held in Vienna from 8-11 Feb 2021. This every two year held conference has gained an ever increasing impact among the pharmaceutical scientists: With up to 1000 submitted abstracts and about 1300 participants it has become a well-established major meeting, attracting scientists from all over the world.
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