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20 May 2005 | By Dr Christopher Haas, Senior Director Pharmaceutical Technology, Schering Plough Corporation
The technology transfer management process reflects an integrated approach to the best practices benchmarked. A well-defined and well-designed technology transfer process is critical for ensuring successful commercial launch. Technology transfer includes manufacturing, packaging and test method transfer to commercial sites.
7 March 2005 | By Olaf Heidenreich, Department of Molecular Biology, Interfaculty Institute for Cell Biology, Eberhard Karls University Tübingen
Small interfering RNAs are irreplaceable tools for the functional analysis of pathological gene products. Therapeutic siRNA development leads to new treatment strategies for gene products, where conventional small molecule approaches have failed.
7 March 2005 | By Thorir D. Bjornsson, MD, PhD, Translational Development, Wyeth Research
The past decade has witnessed a growing interest in biomarkers, previously referred to as pharmacodynamic markers, PD markers, or pharmacologic read-outs. This increasing interest has been largely driven by evolutionary changes in drug discovery and development and in regulatory science1,2,3. One key driver has involved the increasing need to reach…
7 March 2005 | By Dr Daniel Boismenu, Team Leader, Mass Spectrometry Unit, Montreal Proteomics Network
The Réseau Protéomique de Montréal Proteomic Network (RPMPN) was created in the year 2000 through funding from Genome Canada, Genome Québec and the Canadian Foundation for Innovation. For the past five years, the RPMPN has been involved in the Cell Map Project, which involves cell biologists from the Université de…
7 March 2005 | By Donald G. Robertson, Metabonomics Evaluation Group, Departments of Worldwide Safety Sciences and Michael D. Reily, Discovery Technologies, Pfizer Global Research and Development
Metabonomics has been defined as the “the quantitative measurement of the time-related multi-parametric metabolic response of living systems to pathophysiological stimuli or genetic modification”1. In simple terms it is a powerful tool for assessing the metabolic component of systemic response.
7 March 2005 | By Dr Brett Paull and Prof. Pavel Nesterenko, Research Scientists, National Centre for Sensor Research, Dublin
Ion chromatography (IC) is currently used throughout chemical and pharmaceutical industries for the quantitative determination of inorganic and organic anions and cations in a variety of matrices from both raw materials to finished products. In most cases, suppressed IC is utilised, particularly for the determination of inorganic anions and this…
7 March 2005 | By Jukka Rantanen, Senior Research Scientist, Viikki Drug Discovery Technology Centre, University of Helsinki
There is an increasing demand for new approaches to understand the chemical and physical phenomena that occur during pharmaceutical unit operations. Obtaining real-time information from processes opens new perspectives for safer manufacture of pharmaceuticals. Raman spectroscopy provides a molecular level insight into processing and it is therefore a promising process…
7 March 2005 | By Ann F. Hoffman, Senior Principal Scientist, Roche Discovery Technologies
There is no single solution to achieving these goals; however there are underutilised tools that provide drug discovery efforts with richer data sets for more prudent/intelligent decision making. Tools that have already emerged into the forefront to await impact upon the process include the use of automated patch clamp technologies…
7 March 2005 | By Dr. Ulrich Schopfer, Global Head of Compound Management, Dr. Frank Hoehn, Laboratory Head, Automation, Matthieu Hueber, Automation Engineer, Novartis Institutes for BioMedical Research
Dispensing of solids is still a demanding task in laboratory automation. The solubilisation of High Throughput Screening (HTS) libraries is one of the most challenging problems in this area, since millions of different substances have to be processed by the same technology.
7 March 2005 | By Oliver Bruttger, Danielle Folio, Christine Niklaus and Johannes Ottl, Novartis Institute for BioMedical Research, Lead Discovery Center Basel
Research and development for a pharmaceutical company is a difficult and lengthy process. It stretches from the discovery phase to preclinical and clinical development stage, through the drug approval period ultimately to clinical application. The discovery research phase is one of the early key processes. The research starts with target…
7 March 2005 | By Dirk C. Hinz, Ph.D., Schering AG, Corporate CMC Development, In-Process Control Dept.
Pharmaceutical manufacturing occurs in a highly regulated environment, where most of the manufacturing is performed in batches, in stop-and-go steps and with off-line testing of product quality. Additionally, due to patent restrictions, there is always ‘speed to market’ pressure.
7 March 2005 | By Simon Routledge, Head of GMP Manufacturing, Eden Biodesign
A desire to build on the bio-manufacturing expertise already present in North West England and the requirement to support UK biotechnology growth as a whole has led the North West Development Agency to sponsor the establishment of a National Biomanufacturing Centre (NBC) in Liverpool. The NBC is due to open…
7 March 2005 | By Dr Monika Sauter, Director, Global Quality Assurance Operations and Tim Lloyd, Editor
A safe, effective and state-of-the-art cleanroom requires significant investment and manpower. To sustain long-term development and meet objectives, as well as maintain a contamination-free environment, it is essential that sound procedures are in place from day one, as part of a dedicated management program.
7 March 2005 | By Professor Richard Dalby and Yang Guo, University of Maryland School of Pharmacy, Julie Suman, Next Breath LLC
In 2003 worldwide sales of allergic rhinitis nasal sprays alone were valued at US$2.4B (IMS, Valois), up from 2002 worldwide sales of all over-the-counter (OTC) nasal sprays except steroids, estimated at US$820M (IMS, Valois). That’s a significant amount of drug administered via the nose every year (Figure 1). With a…
