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Implementation of high-throughput quality control processs within compound management

31 August 2011 | By Jerome Giovannoni and J.M. Peltier, Novartis

The constant growth of compound collections, combined with screening efforts on more challenging targets, is creating an increasing demand for quality control in order to ensure the integrity of the compound solutions being tested. This is true throughout the early drug discovery pipeline, from hit identification to lead nomination. Novartis…

Emergence and identification of new designer drug products from the internet

31 August 2011 | By S. Assi, S. Fergus, J.L. Stair, O. Corazza and F. Schifano, University of Hertfordshire

Designer drugs represent a rapidly expanding phenomenon particularly facilitated by their internet availability. These drugs are continuously emerging as analogues of controlled substances (amfetamine, aminoindane, cathinone, phencyclidine, etc) and once an analogue has been banned, another replacement analogue appears on the market. They are often made in unlicensed laboratories which…

Thermodynamics and kinetics driving quality in drug discovery

31 August 2011 | By Geoff Holdgate, AstraZeneca

Recently, there has been renewed interest in using thermodynamic and kinetic data, alongside empirical rules (particularly focused upon cLogP and molecular weight) and guiding metrics such as ligand efficiency and lipophilic ligand efficiency developed for fragments, leads and drugs in order to facilitate the design of compounds with a greater…

Under the microscope: Steve Delity

31 August 2011 | By

Rapid Micro Biosystems is a privately owned, venture backed company with headquarters in Bedford, Massachusetts. Since launching its GrowthDirect™ System in 2008, the company has now moved into Europe with the opening of its new demo centre in Darmstadt, Germany in June 2011. So, how does CEO Steve Delity view…

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…

Detection of microorganisms using cellular component-based rapid method technologies

20 June 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the third in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2011. In my last article, I provided an overview of viability-based rapid microbiological methods (RMMs), such as flow and solid-phase cytometry. In this article, we will review some of…

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…

microRNAs and their potential involvement in HIV infection

20 June 2011 | By Guihua Sun, Irell & Manella Graduate School of Biological Science and Department of Molecular and Cellular Biology, Beckman Research Institute of the City of Hope and John J. Rossi. Department of Molecular and Cellular Biology Beckman Research Institute of the City of Hope

Treatment and cure of human immunodeficiency virus-1(HIV-1) infection remains one of the greatest therapeutic challenges due to its persistent infection, often leading to acquired immunodeficiency syndrome (AIDS). Although it has been 28 years since the discovery of the virus, the development of an effective vaccine is still far away. Relatively…

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…

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…

Isothermal titration calorimetry and thermal shift assay in drug design

20 June 2011 | By Asta Zubrienė, Egidijus Kazlauskas, Lina Baranauskienė, Vytautas Petrauskas and Daumantas Matulis, Department of Biothermodynamics and Drug Design, Vilnius University Institute of Biotechnology

Isothermal titration calorimetry (ITC) is a method of choice in the pharmaceutical industry for determination of equilibrium binding enthalpy, entropy, and the Gibbs free energy. The method is very powerful for determination of intrinsic binding parameters that could be used in structure-energetics correlations. Here we discuss how to overcome several…

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…

Reducing attrition in drug discovery: The role of biomarkers

20 June 2011 | By Sheraz Gul, Vice President & Head of Biology, European ScreeningPort GmbH

The development of most diseases is often attributed to the dysfunction of the activities of key proteins involved in biological processes and their modulation by a therapeutic agent is considered to offer the potential to alleviate the disease state.

Under the Microscope: Fredrik Sundberg, GE Healthcare

20 June 2011 | By Fredrik Sundberg, Global Director, Strategic Market Development, GE Healthcare

As a company whose expertise includes medical imaging and information technologies, performance improvement and biopharmaceutical manufacturing, GE Healthcare is well placed to support drug discovery innovation and productivity. With the Pharma industry moving away from blockbuster discoveries and focusing more on orphan drugs and rare diseases in the hopes of…

In search of the Holy Grail: Engineering the stem cell niche

19 April 2011 | By Janet L. Paluh, Associate Professor Nanobioscience, College of Nanoscale Science and Engineering, University at Albany SUNY and Guohao Dai and Douglas B. Chrisey, Biomedical Engineering, Rensselaer Polytechnic Institute

There is no other biomedical frontier that offers the stunning potential of human pluripotent stem cells and their progenitors in therapeutic applications to ease human suffering or in their ability to provide insights into development and diseases. Cell plasticity for reprogramming has revealed new opportunities in cell-based therapies and informed…