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PAT and design science

23 May 2007 | By Carl-Fredrik Mandenius, Micael Derelöv, Jonas Detterfelt, Mats Björkman, Division of Biotechnology/IFM and Division of Production Systems/IKP, Linköping University, Sweden

Process analytical technology (PAT) and mechanical design science are interconnected; this article describes how a well-established design modelling approach; the Hubka-Eder model, is applied to the concepts of PAT and quality by design (QBD). The model connects PAT with quality management concepts as defined for PAT by the ICH guidelines…

EuPAT: an initiative to promote progress in the science underpinning PAT

23 May 2007 | By Staffan Folestad, Senior Principal Scientist, AstraZeneca, Sweden; Peter York, Bradford University, UK, and Rasmus Bro, Copenhagen University, Denmark

A new initiative launch has been announced that aims to promote progress in the science underpinning Process Analytical Technology. The core purpose of the EuPAT meeting is the creation of an open and neutral scientific forum for sharing and discussing new findings in cutting-edge scientific research, development of enabling technologies…

The significance and detection of VBNC microorganisms

23 May 2007 | By Dr Paul Newby, Team Leader, Pharmaceutical Microbiology, GlaxoSmithKline

The purpose of this article is to assess the potential significance of Viable but Non Culturable (VBNC) microorganisms in the pharmaceutical industry; consideration is given to the definition of the VBNC state, current methods for the detection of such organisms are outlined and potentially significant new methods, which may impact…

Inducible systemic RNA silencing in Caenorhabditis elegans

27 March 2007 | By Lisa Timmons, Department of Molecular Biosciences, The University of Kansas, Hiroaki Tabara, University of Tokushima, Japan, Craig C. Mello, Howard Hughes Medical Institutes and Department of Cell Biology, University of Massachusetts Medical School, Worcester, Massachusetts and Andrew Fire, Stanford School of Medicine, Stanford University

Introduction of double-stranded RNA (dsRNA) can elicit a gene-specific RNA interference response in a variety of organisms and cell types. In many cases, this response has a systemic character in that silencing of gene expression is observed in cells distal from the site of dsRNA delivery. The molecular mechanisms underlying…

Biomarkers in neurodegenerative diseases

27 March 2007 | By Claudio Carini, MD,PhD,FRCPath, F. VP of Translational Medicine, MDS Pharma

Biomarkers are useful characteristics to evaluate disease progress and targets of therapeutic agents. They are objectively measured and obtained by non-invasive procedures collecting readily accessible matrixes (Blood, CSF). Biomarkers should be easy to detect, specific and reproducible. Most importantly when detected early in the course of a disease they should…

55th ASMS Conference on Mass Spectrometry

27 March 2007 | By EPR

The American Society for Mass Spectrometry (ASMS) was formed in 1969 to promote and disseminate knowledge of mass spectrometry and allied topics. Membership includes over 7,000 scientists involved in research and development. ASMS sponsors the Annual Conference on Mass Spectrometry that is attended by almost 6,000 scientists.

Stathmin immobilisation on a chip using an oligo-cysteine tag

27 March 2007 | By Kazuyuki Nakamura, M.D., Ph.D., Professor and Chairman, Department of Biochemistry and Functional Proteomics, Yamaguchi University Graduate School of Medicine

Protein chip technology is essential for high through-put functional proteomics. In this review the development of a novel protein tag consisting of five tandem cysteine repeats (Cys-tag) at C-terminus of proteins which was covalently attached to the surface of a maleimide-modified diamond-like carbon-coated silicon chip substrate is described.

Neuronal morphology screening as a tool in neuroscience drug discovery

27 March 2007 | By Myles Fennell and John Dunlop, Neuroscience Discovery Research, Wyeth Research

High content screening (HCS) has now become integrated into all aspects of drug discovery from target identification and validation to hit generation and lead optimisation through to toxicological profiling. In neuroscience, the ability to perform automated neurite outgrowth and neuronal morphology screening has been a significant driver of HCS implementation.…

Novel strategies for antidepressant drug discovery

27 March 2007 | By Chad E. Beyer, PhD, Discovery Neuroscience, Wyeth Research

Despite marked advances in our understanding of chemical transmission, many of the complex processes, namely, our appreciation of the varying roles of neurochemicals in disease etiology, are still being investigated. To aid in this exploration and to monitor the extracellular levels of neurochemicals in living tissue systems, techniques such as…

HTS technologies to facilitate chemical genomics

27 March 2007 | By Douglas S. Auld, James Inglese, Ajit Jadhav and Christopher P. Austin, NIH Chemical Genomics Center, National Institutes of Health, Bethesda, G.Sitta Sittampalam, Chahrzad Montrose-Rafizadeh and James E. Mcgee, Lead Generation & Lead Optimization Biology, Discovery Chemistry Research & Technology and Philip W. Iversen, Global Discovery & Development Statistics, Eli Lilly & Company

Industrial scale technologies developed and applied within the pharmaceutical industry for the purpose of drug discovery have recently been adopted by many research laboratories for the purpose of facilitating chemical genomics. Taking full advantage of these technologies will require education in high-throughput screening assay systems as well as new methods…

Industry Insight: United they stand

27 March 2007 | By EPR

Late last year, Thermo Electron and Fisher Scientific merged to become Thermo Fisher Scientific, Inc., the world leader in serving science. European Pharmaceutical Review spoke to Marc Casper, vice president of Thermo Fisher Scientific and president of its analytical technologies group to discover the impact this has had on the…

Calorimetry for polymorph detection

27 March 2007 | By Simon Gaisford PhD., School of Pharmacy, University of London and Michael AA O’Neill PhD., Department of Pharmacy and Pharmacology, University of Bath

Characterising the properties of a material, understanding how these properties change in relation to local environment and quantifying potential interactions with other species are facets central to any drug development programme. Not understanding and, more importantly, not controlling these factors can have serious consequences for a pharmaceutical, from irreproducible processing…

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