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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
Detection of microorganisms using cellular component-based rapid method technologies

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…

Figure 1 (A) the increase in mass resolving power of commercially available instruments from 1996 to the present and (B) the improvement in mass accuracy over the same time period
Figure 1 (A) the increase in mass resolving power of commercially available instruments from 1996 to the present and (B) the improvement in mass accuracy over the same time period

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…

Figure 1 The HIV-1 genome
Figure 1 The HIV-1 genome

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…

Figure 1 Energy level diagram of Rayleigh and Raman scattering
Figure 1 Energy level diagram of Rayleigh and Raman scattering

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…

Figure 1 High content screening analysis of HepG2 cells stained under control (A,C,E,G), or 24 (B,D,F) and 72 (H) h incubations with 10-6 / 10-5 M doxorubicin with different fluorescent probes, i.e.. Hoechst 33342, Fluo-4, TOTO-3 and TMRM
Figure 1 High content screening analysis of HepG2 cells stained under control (A,C,E,G), or 24 (B,D,F) and 72 (H) h incubations with 10-6 / 10-5 M doxorubicin with different fluorescent probes, i.e.. Hoechst 33342, Fluo-4, TOTO-3 and TMRM

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…

Figure 1 Comparison of ITC and TSA data for lead compound 3b binding to the N-terminal domain of Hsp90 target protein4. Left panels show ITC data, right panels – TSA data. Upper panels (a) and (c) show raw data while lower panels show the dosing curves
Figure 1 Comparison of ITC and TSA data for lead compound 3b binding to the N-terminal domain of Hsp90 target protein4. Left panels show ITC data, right panels – TSA data. Upper panels (a) and (c) show raw data while lower panels show the dosing curves

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…

Flow Cytometry
Flow Cytometry

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…

Sheraz Gul
Sheraz Gul

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…

Figure 1. Engineering the Stem Cell Niche. The ability to assembly natural and manmade components into idealized biosynthetic 3D architectures requires a detailed understanding of the environment, along with the technology and expertise to manipulate them. This multiscale and multi-expertise approach is expected to lead to unprecedented breakthroughs in tissue engineering and biofabrication that benefit human health for an improved quality of life.
Figure 1. Engineering the Stem Cell Niche. The ability to assembly natural and manmade components into idealized biosynthetic 3D architectures requires a detailed understanding of the environment, along with the technology and expertise to manipulate them. This multiscale and multi-expertise approach is expected to lead to unprecedented breakthroughs in tissue engineering and biofabrication that benefit human health for an improved quality of life.

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…

AstraZeneca announces collaborations to use CRISPR technology for genome editing across its drug discovery platform
AstraZeneca announces collaborations to use CRISPR technology for genome editing across its drug discovery platform

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
The increasing role of toxicology in early decision making processes

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…

Figure 1 Process to obtain UV Scans of standards and assay samples. Solid compound samples are weighed
Figure 1 Process to obtain UV Scans of standards and assay samples. Solid compound samples are weighed

UV-Vis scan-based quality control of assay-ready plates for improved data integrity

19 April 2011 | By Gary K Smith, M Anthony Leesnitzer, Lois L Wright, Iona Popa-Burke, Trevor Casserly, Luke Miller, Melissa Gomez & Iris Scherer, GlaxoSmithKline

Quality biological data requires both a high quality assay and a high quality compound. While assay quality is very closely monitored and has been intensively studied in the past, the quality of the final compound solutions being tested in an assay has received little attention. Quality of these samples is…