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Pharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
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Articles
Under the microscope: Steve Delity
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
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…
Using translational pharmacology biomarkers to drive earlier decision making
19 April 2011 | By Magnus Ivarsson, Head of Physiological Biomarkers, Pfizer and Mark Fidock, Head of Quantitative Biomarkers, Research Enabling Group, Pfizer
The current high rate of attrition during drug development is unsustainable. An increasing amount of the cost of developing a new drug is made up of the investment in molecules that fail at some point during the process and the later that failure occurs, the more costly it will be.…
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…
is it ever right to sue a client?
19 April 2011 | By Jim Kinnier Wilson, Partner, Manches
Imagine that you are part of a small biotech company, BiotechCo, whose business is the development of delivery systems for pharmaceutical products. One of your team, who is in charge of developing sales with a large pharmaceutical company, Pharma Co, came to you three months ago with the possibility of…
