Process Analytical Technologies (PAT) in the pharmaceutical industry
European Pharmaceutical Review brings you a comprehensive guide to the current developments and possible future innovations within Process Analytical Technologies...
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Articles
RNAi: an attractive choice for future therapeutics
23 May 2007 | By John J. Rossi, Division of Molecular Biology, Beckman Research Institute of the City of Hope, Graduate School of Biological Sciences, Duarte, United States
RNA interference (RNAi) is a regulatory mechanism of most eukaryotic cells that uses small double stranded RNA (dsRNA) molecules as triggers to direct homology-dependent control of gene activity (Almeida and Allshire 2005).
Biomarker discovery and validation in clinical proteomics
23 May 2007 | By Professor Stephen R Pennington, Proteome Research Centre, Conway Institute of Biomolecular and Biomedical Sciences, University College Dublin
Until recently the use of proteomics in the biomedical arena has included programmes aimed at the elucidation of cellular responses to extracellular stimuli by known and potential drugs. It has been anticipated that these will lead to the elucidation of the basic mechanisms of cellular responses, potential identification of new…
The handling and analysis of large scale high content screening data
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…
Launching an HTS campaign to discover new antivirals
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…
Calorimetry for amorphous content quantification
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…
Ion channel electrophysiology in pharmaceutical research
23 May 2007 | By Daniel Konrad, Simon Hebeisen, and Urs Thomet, bSys GmbH
Ion channels are well recognised as targets for a vast range of disease states and conditions. The process of discovering drugs is influenced by the biological confidence in the rationale of the screening approach and the screenability. Various methods have been gathered around the gold standard of manual patch-clamping that…
Automated classification of crystallisation images
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…
Spray-freeze-drying in the manufacture of pharmaceuticals
Over the last decade, the development of new drug delivery methods and devices for dry powder inhalation1, needle-free intradermal powder injection2 or sustained parenteral drug delivery3 has led to an increasing demand for powder formulations incorporating an active pharmaceutical ingredient (API)4,5.
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.
