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21 July 2007 | By Robert Johnson, Director, Dialogue
The modern microbiological laboratory needs to change and become more innovative in its approach to microbial detection, enumeration and identification.
European Pharmaceutical Review brings you a comprehensive guide to the current developments and possible future innovations within Process Analytical Technologies...
23 May 2007 | By Karol Kozak and Benjamin Eshun, Data Handling in TDS, Max Planck Institute of MolecularCell Biology and Genetics, Germany. Jeff Oegema, CEO, Scionics Computer Innovation, GmbH
Data management has become one of the central issues in High Content Screening (HCS) as it has high potential within predictive toxicity assessments. In particular, HCS applying automated microscopy requires a technology and system which is capable of storing and analying vast amounts of image and numeric data. HCS data…
23 May 2007 | By Colleen B. Jonsson, Ph.D., Program Leader, Emerging Infectious Disease Research and E. Lucile White, Manager, High-Throughput Screening Center and Enzymology Laboratory, Southern Research Institute, Birmingham, AL, United States
There are over 300 human viruses that have no treatment, vaccine or antiviral. Unfortunately, only sixty-two drugs are approved by the US Food and Drug Administration (FDA) for the treatment of six different viral illnesses. Of these, 45% are for the treatment of HIV/AIDS. The remaining drugs offer treatments that…
23 May 2007 | By Simon Gaisford PhD and Rita Ramos PhD, School of Pharmacy, University of London
In the previous article (European Pharmaceutical Review, Issue 2, 2007) an introduction to calorimetry was given and its application to polymorph characterisation, discussed. Another area of application of growing importance is quantification of (usually small) amorphous contents. A requirement to demonstrate the presence or absence of amorphous material is becoming…
23 May 2007 | By Julie Wilson, York Structural Biology Laboratory, Department of Chemistry, University of Heslington, York, UK
The findings of many crystallisation experiments are required in order to identify conditions that will produce diffraction quality crystals. The use of robots has increased the number of experiments performed in most laboratories and, in structural genomics centres, tens of thousands of experiments can be produced every day. As each…
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…
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…
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.…
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…
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…
27 March 2007 | By Joydeep Ganguly, PAT Group Lead and Gerrit Vogel, Senior Engineering Manager, Talecris Biotherapeutics
This case study provides a comprehensive look at Talecris1 Biotherapeutics’ approach to PAT and automation followed by examples of PAT deployed on a bioprocess. It introduces the concept of integrated and scalable automation, provides a comparison of automation concepts and explains how the selected automation effectively supports initiatives such as…
25 January 2007 | By EPR
Introducing the Panel...
25 January 2007 | By Ronan O’Kennedy, Biopharmaceutical Process Development, Biopharmaceutical CEDD, GlaxoSmithKline
The biopharmaceuticals industry has undergone a number of revolutions in the past decade, not least the variety of ‘omics’ that focus on high throughput technologies to identify new product targets and can rapidly characterise those targets at small scale. However, it has been widely recognised that the technology used in…
28 November 2006 | By Colleen B. Jonsson, Program Leader, Emerging Infectious Diseases Research, Southern Research Institute
Over the past few decades we have experienced a dramatic increase in the rate of emergence and re-emergence of infectious diseases1,2. Many of these diseases, such as SARS, resulted in fewer than 1,000 deaths, but caused an estimated 2 per cent decline gross domestic product in East Asia. The economic…
