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Polyphasic approach to microbial identification

28 November 2006 | By Hans-Joachim Anders, Marion Keller, Manfred Berchtold and Werner Hecker, Novartis Pharma Stein AG, Biological and Microbiological Services, Switzerland

The identification of microorganisms from the pharmaceutical production environment has gained an ever greater importance in modern times. Thus the new Aseptic Processing Guide of the FDA recommends the identification of detected isolates from the critical clean room area (grade A or ISO 5) down to the species level and…

Committee E55 – an update

28 November 2006 | By Pat Picariello, Director of Developmental Operations, ASTM International

Since its creation in December 2003, ASTM International Committee E55 on Manufacture of Pharmaceutical Products has grown in size as well as global relevance. Recent liaison relationships have been established with the ISPE and the European Compliance Academy (ECA) regarding their internal distribution of E55 draft standards for the purpose…

The right approach to human therapy

28 September 2006 | By Dr Simone Hess, Max-Planck-Institute for Infection Biology

The RIGHT (RNA Interference Technology as Human Therapeutic Tool) consortium consists of 18 research institutions and four companies from nine European countries. The project has been funded as an integrated project by the European Commission’s Sixth Framework Programme for Research and Development (FP6) since January 2005. Thomas F. Meyer from…

An essential role for the Michael Barber Centre

28 September 2006 | By Simon J Gaskell, Director of the Michael Barber Centre for Mass Spectrometry in the School of Chemistry and the Manchester Interdisciplinary Biocentre and Isabel Riba-Garcia, Research Fellow, Michael Barber Centre.

The development of proteomics has been based very heavily on the suite of analytical techniques encompassed by mass spectrometry and associated methods. It is therefore appropriate that the work of the Michael Barber Centre for Mass Spectrometry (MBCMS, named for the inventor of, inter alia, the fast atom bombardment ionisation…

The role of HTS in eADMET profiling

28 September 2006 | By Werner Stuermer, Altana Pharma

Historically (until the late 1980s), compounds discovered by phenotypical in vivo screens were at least characterised with implicit ADMET data. An attractive compound in these test systems was available at the (usually unknown) target; had a minimal toxicological profile (the animal did not die immediately) and gave phenotypical (High-Content) information…

Bottlenecks and potential improvements

28 September 2006 | By Carlo E.A. Jochems and Stefan Herzig, Department of Pharmacology, Faculty of Medicine, University of Köln

Ion channels are membrane proteins that regulate the entrance and departure of specific ions from cells, thus influencing the physiology of all cells. These ion flows also underlie electrical impulses required for sensory and motor functions of the brain, control of contraction of heart, skeletal, smooth and vascular muscle, as…

Wyeth forges ahead

28 September 2006 | By Graham Cook Ph.D., Director Technology and External Supply, EMEA, Wyeth

Is the pharmaceutical manufacturing environment of today becoming more challenging? There is increasing pressure to control or reduce costs because of the limitations on healthcare budgets. Asset utilisation, operating efficiencies and cycle times in the pharmaceutical industry generally compare unfavourably with other high technology industries. Despite the resources invested in…

Streamlining with automation and robotics

28 September 2006 | By Bart Hazes, Dept. of Medical Microbiology & Immunology, University of Alberta and Bernhard Rupp, q.e.d. life science discoveries, inc.

Protein crystallography has been embraced by the pharmaceutical industry to accelerate and rationalise the drug development process. In this role, success rates, throughput and turnaround times have become key competitive factors, and nearly every stage in the protein crystallography process has been targeted for automation using robotics and advanced software.…

Cell-based imaging

28 September 2006 | By Jinghai J. Xu, Ph.D., Margaret C. Dunn, Arthur R. Smith, Pfizer Global Research and Development

Traditionally, in vivo histopathological findings have been used as part of standard readouts for safety assessment of new chemical entities (NCEs). The process typically involves dosing animals with NCEs for varying amounts of time, harvesting their major organs at the end of the study, preparing tissue sections and slides and…

The right technology, at the right time

28 September 2006 | By EPR

The growing popularity of Electronic Data Capture (EDC) is indicative of a broad recognition that EDC as a method of data capture offers significant realisable benefits. Developers of drugs that use EDC within their clinical research processes will have a significant competitive advantage, bringing new drugs and therapies to market…

The current market and future trends for RMM

28 September 2006 | By Tony Cundell, Director, Pharmaceutical Sciences – Microbiology, Schering Plough Research Institute

Following on from our latest report in Issue 4 in which we outlined independent views on ‘solutions for the next stage’ in Rapid Microbiological Methods (RMM) from some of the industry’s leading names, Tony Cundell follows up with his own thoughts on this exciting field.

Essential techniques for development

28 September 2006 | By Dr Danielle Giron, President, Swiss Society for Thermal Analysis & Calorimetry

Thermal analysis methods and coupled techniques are well established procedures in material science. Due to the different information delivered, thermal analysis methods are concurrent or complementary to other analytical techniques such as spectroscopy, chromatography, melting point determination, loss on drying, assay, for identification, purity and quantitation. They are basic methods…

Quantitative PCR assays in clinical drug development

28 September 2006 | By Michael E. Burczynski, Ph.D. and Ole E. Vesterqvist, Ph.D. Biomarker Laboratory, Clinical Translational Medicine, Wyeth Research

Biomarkers (biological markers) have become an integral part of both drug discovery and drug development and play an important role in the transition of potential new drugs from discovery into clinical drug development. In the past, most biomarkers were proteins/peptides and metabolites measured by technologies such as immunoassays, enzymatic assays,…

MitoCheck: checking mitosis

20 July 2006 | By Dr Yan Sun, MitoCheck Project Manager, Institute of Molecular Pathology

MitoCheck is a multi-national, multi-disciplinary research project on cell cycle control. It is funded by the European Union within its 6th framework program (FP6). Leading scientists from 11 research institutes, universities and industry in Austria, Germany, UK, Italy and France with a wide range of expertise in molecular and cell…