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In this PAT supplement: The historical development of the FDA's PAT initiative and its present course; Implementation of modelling approaches in the QbD framework: Examples from the Novartis experience; Challenges in development and implementation of spectroscopic techniques as PAT Analysers...
13 December 2011 | By Michael J. Miller, President, Microbiology Consultants
This is the sixth and final article in our series on Rapid Microbiological Methods (RMMs) that have appeared in European Pharmaceutical Review during 2011. In our last article, we reviewed the world of nucleic acid amplification technologies, including PCR-DNA amplification, RNA-based reverse-transcriptase amplification, 16S rRNA typing and gene sequencing for…
13 December 2011 | By Andrew A. Parsons, Vice President Preclinical Drug Development, GlaxoSmithKline and Steve Street, Vice President, Head of Research Centres of Emphasis, Head of WRD Continuous Improvement, Pfizer and William Strohl, Vice President of Biologics Research, Centocor R&D, a division of Johnson & Johnson Pharmaceutical Research & Development and Eckhard von Keutz, Senior Vice President, Head Global Early Development, Bayer HealthCare
External economic pressures have been identified as the major driver for the pharmaceutical outsourcing market. Over and above the fiscal advantages of adopting this strategy, what other benefits and indeed risks do you see associated with this approach? Steve Street: We definitely began our out - sourcing efforts based on…
13 December 2011 | By Ole Pless and Sheraz Gul, European ScreeningPort GmbH
Multiple Sclerosis (MS) is an autoimmune disease leading to a chronic inflammation and degeneration of the central nervous system. It is one of the major neurological diseases with approximately 2.5 million suffering patients worldwide. Until now, the underlying mechanisms have not been fully elucidated, but the cause of the disease…
13 December 2011 | By Henri Xhaard, Head of Computational Drug Discovery Group, Centre for Drug Research, University of Helsinki
The central location of G protein-coupled receptors (GPCRs) at the interface between the interior and exterior of cells, as well as their key role in signalling events, make GPCRs a prominent class of pharmaceutical targets. To date, approximately 40 per cent of known drugs are thought to act on GPCRs…
In order to advance the identification of new drug targets and disease biomarkers, experimental tools for the systems-level analysis of signalling networks are required. Approaches for a targeted analysis of cellular proteomes have improved in recent years. Notably, the reverse phase protein microarray (RPPA) approach offers great advantages due to…
13 December 2011 | By Sheraz Gul, Vice President and Head of Biology, European ScreeningPort GmbH
The pre-clinical phase of drug discovery spans a period in the region of five years and requires contributions from multi-disciplinary teams often working at different sites. These teams can generate significant amounts of data which are processed using standard as well as specialist software. The recording of a substantial amount…
13 December 2011 | By Nouf N. Laqtom, University of Edinburgh & King Abdulaziz University and Amy H. Buck, University of Edinburgh
microRNAs (miRNA) are a class of non-coding RNA that regulate the precise amounts of proteins expressed in a cell at a given time. These molecules were discovered in worms in 1993 and only known to exist in humans in the last decade. Despite the youth of the miRNA field, miRNA…
13 December 2011 | By Mirco Castoldi. Department of Pediatric Hematology, Oncology and Immunology University of Heidelberg
Cell-free nucleic acids circulating in human blood were first described in 19481. However, it was not until the work of Sorengon and colleagues was published in 19942 that the importance of circulating nucleic acid (cfNA) was recognised. Today, the detection of diverse type of cfNA3 in blood and other body…
13 December 2011 | By Nalini A.L. Mehta & David J. Dow, Molecular and Cellular Technologies, Platform Technology and Science, GlaxoSmithKline and Anthony M. Battram, Molecular and Cellular Technologies, Platform Technology and Science, GlaxoSmithKline & Department of Life Sciences, Imperial College London
In recent years, the development of Next Generation DNA Sequencing (NGS) technology has significantly impacted molecular biology research, resulting in many new insights and discoveries. NGS technology goes beyond traditional DNA sequencing with applications that reach across the central dogma of molecular biology from DNA to RNA and protein science.…
13 December 2011 | By Mingshi Yang, Faculty of Pharmaceutical Sciences, University of Copenhagen
Spray drying is a widely used technical method to produce fine particles, coarse powders, agglomerates or granulates in various industries. The characteristics of the particles produced by this method can be controlled and the particle properties can be maintained as constant throughout a continuous operation. The product from this process…
13 December 2011 | By Philip Irving, President, FOSS NIRSystems, Inc.
FOSS NIRSystems, Inc. has a long, complicated and rich history tracing back to 1966 when NEOTEC Corporation was founded. Through a number of acquisitions and mergers, NIRSystems was trademarked in 1989 and bought by Perstorp Analytical, before the company was bought by FOSS in 1997, strengthening the company’s pharmaceutical division.…
