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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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MedPharm’s CSO and University of Reading Professor co-author new book on dermal formulation development
MedPharm’s Chief Scientific Officer and Co-Founder, Professor Marc Brown and University of Reading’s Professor Adrian Williams have co-authored the new book: ‘The Art and Science of Dermal Formulation Development”. It is the latest addition to ‘Drugs and the Pharmaceutical Sciences’, a series of textbooks and monographs published by CRC Press.
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White Papers |
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The Impact of Components on Drug Quality and Risk Mitigation
West Pharmaceutical Services, Inc.
Expectations for quality by regulatory agencies are increasing at a very fast pace, especially for prefilled drug delivery formats, thanks to increased focus on reducing risk to patient safety. The trend has resulted in delays for new drug applications, more recalls of marketed products and even drug shortages if the container system and drug contents are suspect for quality issues. The pharmaceutical market is now requiring manufacturers of containers and components to meet new expectations with a quality culture and very high product reliability. The need to bridge the gap and provide superior quality products has been a driver for manufacturing technology investments, more robust control strategies and the introduction of next generation elastomer components.
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Industry Events |
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World Pharma Week 2019
17-20 June 2019, Seaport World Trade Center, Boston
World
Pharma Week will bring together a unique and international mix of large and
medium pharmaceutical and biotech companies, CROs, leading universities and
clinical research institutions, emerging companies and tool providers—making it
a perfect meeting-place to share experience, foster collaborations across industry
and academia, and evaluate emerging technologies.
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