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| home > ebr > Autumn 2016 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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EBR’s Editor Deborah O’Neil outlines October’s edition by underpinning recent pharma failures, and using them as a foundation upon which to build new R&D successes. Fresh research approaches and subsequent new therapies are gradually moving towards much needed cures and treatment.
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BC Platforms’ Timo Kanninen talks collaboration and harmonisation, as he explains the need for pharma companies to get the most out of their data – he recommends the use of biobanks to achieve this.
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NDA Group’s Beatriz Lima tells us that the advent of innovative technology that supports the identification of cellular responses could help to renew molecular biology studies, and tackle ongoing research concerns.
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There has been considerable growth in the use of virus-like particles across the whole pharma landscape, observes ARTES Biotechnology’s Volker Jenzelewski. These can aid new results and can contribute to safe and efficacious vaccines.
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Sabine den Hartogh, Stefan Braam and Maria Vlaming of Pluriomics believe that assessing the cardiac safety of drug candidates is vital for drug discovery – and human induced pluripotent stem cell-derived cardiomyocytes are key for this process.
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CPhI Worldwide returns, and will be taking place this year in Barcelona on 4-6 October 2016. The event offers networking opportunities, as well as encourages collaboration among pharma products and business solutions.
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The UK’s decision to leave the EU has caused many pharma companies to reconsider their position within the sector. Industry advisor Emile Bellott looks into the impact the referendum result may have on these organisations.
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Understanding the mAb structure-function relationship is a crucial factor in biosimilar development, points out Dr Terry Gray at Sartorius Stedim. This way, it is possible to significantly reduce wasted resources in the manufacturing process.
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According to Dr Piotr Piotrowski and Dr Anna Baran at KCR, it is now more important than ever to stay on top of new regulations and trends – especially in the neuroscience field. Many of these, however, can generate more issues.
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According to Nicola J McCarthy and Jonathan D Moore at Horizon Discovery, the field of immuno-oncology is rapidly advancing due to the use of the CRISPR-Cas9 system. This technology can improve both treatment and patient benefit.
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It is evident that biosimilar clinical trials are growing in popularity, with one drug in particular – rituximab – leading the way. ICON’s Kyoo Jung Shim and Petra Roos explore its ongoing development.
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Patrick Harrison at University College Cork reveals that a breakthrough has been made: stem cell and gene-editing research could accelerate finding a cure for a variety of disease-causing mutations, as well as enabling tailored treatment.
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Sylvie Ponchaut of BioWin introduces the Belgian region of Wallonia and its excellence in cellular therapy studies; its business ventures, employment level and consistent results output make it a valuable location for research.
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CellGenix’s Bernd Leistler reminds the pharma community that rules and regulations continue to tighten, and that it is important to maintain high quality levels in raw materials, in order to ensure the safety and efficacy of any therapy.
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Dr Carl J Christel of Sirion Biotech believes that there is potential for a fresh approach to R&D in the future; the instigation of adeno-associated virus design techniques could, with further optimisation, overcome many clinical challenges.
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Abbexa’s Connor McCay and Sabrina Calabressi discuss the role of antibody therapies and the ways in which they continue to develop and grow. In fact, recent research shows that these treatments may soon be able to cure inherited illnesses.
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Recent research suggests that ctDNA may be the best alternative to traditional liquid biopsy procedures, which are often intrusive and unreliable, say Paul Elvin and Glen Clack at Aptus Clinical.
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News and Press Releases |
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Wire it with pride with Teknomeks latest modular storage options
Teknomek has extended its modular shelving range to offer customers more options to make optimal use of the storage space available to them. The hygienic units are built from 304 grade stainless steel and feature wire shelving, which does not interrupt air circulation and prevents from dust settling.
More info >> |
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White Papers |
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The BioPharmaSpec Approach”: Mass Spectrometry Based Host Cell Protein Identification and Quantitation
BioPharmaSpec
1. Introduction
As part of the development of any biopharmaceutical product, the impurities present must be examined, minimized and where possible characterized (1). These impurities fall into two broad categories: product-related impurities (derived specifically from the drug product itself) and process-related impurities (derived from material associated with the production, processing or purification of the sample). Host cell proteins (HCPs) are process-related impurities that require specific analysis due to the multitude of naturally occurring proteins expressed in the production cell line.
More info >> |
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Industry Events |
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PDA Universe of Pre-Filled Syringes and Injection Devices
8 October - 9 November 2018, Loews Royal Pacific, Orlando, FL
At the 2018 PDA Universe of Pre-filled Syringes and Injection Devices,industry and regulatory experts will share experiences, new developments,
regulatory considerations, challenges, and industry trends and best practices.
This is a must-attend event for all industry professionals involved in the
development, manufacturing, testing, or marketing of pre-filled syringes and
injection devices.
More info >> |
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