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22 October 2013 | By David Elder, JPAG and GlaxoSmithKline / Andrew Teasdale, JPAG chairman and AstraZeneca
Historically, control over metal impurities has been achieved via pharmacopoeial heavy metals limit tests, e.g. United States Pharmacopeia (USP) .
22 October 2013 | By Birthe V. Nielsen, Faculty of Engineering and Science, University of Greenwich
Neuromodulators such as calcitonin gene-related peptide (CGRP) and vasoactive intestinal peptide (VIP) act as biomarkers for pain assessment (pre-clinical). These markers can be detected at low concentrations by Electrospray Ionisation (ESI) Mass Spectrometry (MS). Currently, little is known about the factors affecting responsiveness in the ESI process though the response…
22 October 2013 | By Diana Russom (Department of Information Technology Systems, Beckman Research Institute of the City of Hope) / Amira Ahmed and Nancy Gonzalez (Laboratory for Cellular Medicine, Beckman Research Institute of the City of Hope) / David L. DiGiusto (Laboratory for Cellular Medicine and Department of Virology, Beckman Research Institute of the City of Hope)
The volume of data generated in modern medical research centres is growing exponentially and becoming more diverse as advancements in automation and biotechnology transform the basic operations of these laboratories and clinics. Patient care and laboratory instrumentation generate data at a rate that rapidly outpaces the ability to track and…
22 October 2013 | By Amancio Carnero, Instituto de Biomedicina de Sevilla, Consejo Superior de Investigaciones Científicas
There is an urgent need to predict which treatment will report the most benefit to a patient with cancer. To that end, scientists are exploring any possible biomolecule in the organism that can mark each individual for its adequate treatment. If achieved, it will open a personalised medicine era.
22 October 2013 | By Mark Wade, Center for Genomic Science of IIT@SEMM
Protein-protein interactions (PPI) form the backbone of all cellular signalling networks, and aberrant PPI contribute to the pathology of several diseases. Thus, strategies to identify PPI modulators are expected to be therapeutically beneficial. However, there are very few examples of clinically approved PPI modulators, reflecting the difficulties of identifying effective…
22 October 2013 | By Michael J. Miller, President, Microbiology Consultants, LLC and Suzan Mohammed Ragheb, Department of Biotechnology, The Nile Company for Pharmaceuticals and Chemical Industries
Rapid microbiological methods (RMM) have gained popularity and acceptance within a number of industry sectors, including food and beverages, diagnostics, environmental, personal care and pharmaceuticals. In recent years, many firms have successfully validated and implemented RMMs for a wide variety of applications. However, many geographic areas around the world still…
Read the free digital version of the August / September edition of European Pharmaceutical Review magazine...
IN this Informatics In-Depth Focus: Using LIMS for biobanking and implementing LIMS for research; Biologics development and ELN: A good match?; Informatics Roundtable...
In this RMMs & Environmental Monitoring In-Depth Focus: The rapid microbiological methods revolution; Controlling contamination in the pharmaceutical industry; Rapid Micro Methods Roundtable...
The International Conference on Harmonisation (ICH) guideline for the Validation of Analytical Procedures (ICHQ2(R1)) currently covers validation procedures for the four most common analytical tests: identification tests, quantitative tests for impurities, limit tests for the control of impurities and quantitative tests for the active moiety(ies) in APIs (active pharmaceutical ingredients)…
20 August 2013 | By Sheraz Gul, Vice President and Head of Biology, European ScreeningPort GmbH
Cysteine proteases are expressed ubiquitously in the animal and plant kingdom and are thought to play key roles in maintaining homeostasis. The aberrant function of cysteine proteases in humans are known to lead to a variety of epidermal disease states such as inflammatory skin disease1. In marked contrast, the serine…
20 August 2013 | By Richard Hayes, Continuous Improvement Manager, Rottapharm
From their headquarters based in Monza, Italy, Rottapharm’s long history of success began in 1961 with the creation of a small laboratory for independent research. The company from its early beginning has continuously invested in research, innovation and development of pharmaceutical products for distribution on a worldwide scale. After acquiring…
20 August 2013 | By Chanda R. Yonzon, Atul Karande, Sai P. Chamarthy and Brent A. Donovan (Merck & Co. Inc)
Raman spectroscopy has emerged as the preeminent analytical tool for a number of applications within drug discovery and development. Advances in the instrumentation, sensor fabrication and data analysis have enabled the wider acceptance of Raman spectroscopy1,2. In discovery, Raman spectroscopy is used to elucidate structural activity relationships3 and to optimise…
20 August 2013 | By Jonathan D. Lippiat, School of Biomedical Sciences, University of Leeds
Early in their undergraduate education, the student is introduced to various types of integral membrane protein: receptors, adhesion proteins, ion channels, ion pumps and ion transporters. As they progress through their studies, they find out that discrete gene families and protein structures are responsible for these different protein classes and…
20 August 2013 | By Niklas Larsson, Linda Sundström, Erik Ryberg and Lovisa Frostne (AstraZeneca)
G protein-coupled receptors are one of the major classes of therapeutic targets for a broad range of diseases. The most commonly used assays in GPCR drug discovery measure production of second messengers such as cAMP or IP3 that are the result of activation of individual signalling pathways. Such specific assays…
