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Analytical techniques

 

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PAT & QbD Supplement (free to view)

20 June 2011 | By Magida Zeaiter - GlaxoSmithKline, Mark Morton - Phoenix Scientific Services, Joachim Ermer - Head of Quality Control Services Frankfurt Chemistry - Sanofi

Featuring articles: "A basis for innovation and continuous improvement of process understanding and control in pharmaceutical product development" by Magida Zeaiter, GlaxoSmithKline, "Flexible processing assures product quality" by Mark Morton, Phoenix Scientific Services and "Quality by design: A lifecycle concept for pharmaceutical analysis" by Joachim Ermer, Head of Quality Control…

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Evolution and revolution in time-of-flight mass spectrometry and its impact on research within the pharmaceutical industry

20 June 2011 | By

Time of flight mass spectrometry (TOF-MS) has been an attractive choice of instrument for many years due to its potentially unlimited m/z range, high-speed acquisition, accurate mass measurement capability and sensitivity. Originally commercialised in the late 1950’s by the Bendix Corporation1, several physical and technical issues of the early TOF…

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Application of deep UV resonance raman spectroscopy to bioprocessing

20 June 2011 | By Lorna Ashton and Royston Goodacre, School of Chemistry, Manchester Interdisciplinary Biocentre, University of Manchester

In recent years, Raman spectroscopy has been successfully applied to bioprocessing, including industrial processes. Raman studies have typically been aimed at measuring accurately both product yields and the presence of secondary products; including glucose and ethanol levels as well as secondary metabolites present in complex non-fractionated fermentation broths1,2. However, Raman…

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High Content Screening for in vitro toxicity testing

20 June 2011 | By Willem G.E.J. Schoonen, Walter M.A. Westerink, Femke M. van de Water and G. Jean Horbach, Department of Toxicology & Drug Disposition, Merck Sharp & Dohme

The application of High Content Screening for in vitro toxicity testing is a relatively new approach in the preclinical research phase of drug development. A battery of tests have been developed for screening on general parameters such as cytotoxicity, while more dedicated assays are available with respect to the identification…

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Implementation of flow cytometric biomarker assays in clinical development

20 June 2011 | By Dianna Y. Wu & Russell Weiner, Clinical Biomarkers and Diagnostics, Merck & Co

Biomarker research has become one of the integral aspects in drug discovery and development. It is broadly utilised to confirm drug mechanism of action (MOA), explore PK/PD correlation, support dose selection and predict response to treatment. Therefore, biomarker data provide valuable information to guide clinical decisions, support drug filings with…

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Thermo Fisher Scientific debuts high-performance benchtop quadrupole-Orbitrap mass spectrometer

1 June 2011 | By

Thermo Fisher Scientific Inc., the world leader in serving science, today introduced the Thermo Scientific Q Exactive high-performance benchtop quadrupole-Orbitrap LC-MS/MS. It is the first commercially available instrument to bring together quadrupole precursor selection and high-resolution accurate mass (HR/AM) Orbitrap mass analysis to deliver high confidence quantitative and qualitative (quan/qual)…

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Thermo Fisher Scientific implements and extends LIMS solution for Eastman Chemical Company

16 May 2011 | By

Thermo Fisher Scientific Inc., the world leader in serving science, today announced that Eastman Chemical Company, a large global manufacturer of chemicals, fibers and plastics, has expanded its deployment of Thermo Scientific SampleManager LIMS (laboratory information management system), which it has used since 2000 in its manufacturing quality control laboratories,…

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The increasing role of toxicology in early decision making processes

19 April 2011 | By Eckhard von Keutz, Senior Vice President, Head Global Early Development, Bayer HealthCare

Clinical development costs are rising at an alarming rate. There is a decreasing success rate for new drug candidate approval and the duration of development is increasing. In other words, industry is spending more and getting less from current drug development efforts. In 2010, 21 new drugs were approved in…

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Molecular drug targets in autophagy

19 April 2011 | By Robin Ketteler, MRC LMCB, University College London

Autophagy is a cellular stress response to diverse stimuli such as starvation, infection and DNA damage. Autophagy plays important roles in the progression of various diseases including cancer, neurodegenerative diseases and Crohn’s disease. Despite recent advances in our understanding of the autophagy machinery, surprisingly little effort has been undertaken towards…