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Articles

Exploring new sources of raw material

20 May 2005 | By Bernhard Schrader, Institut für Physikalische und Theoretische Chemie, Universität Duisburg-Essen and Hartwig Schulz, Federal Centre for Breeding Research on Cultivated Plants, Institute of Plant Analysis

Raman spectroscopy using excitation in the near infrared allows non-destructive Raman analyses of pharmaceutical products as well as of plant or animal tissues. This radiation excites only minimal fluorescence of the samples or impurities and has only minimal photo-physical and photochemical activity. Raman analysis of plants allows the efficient exploration…

Harbinger of change

20 May 2005 | By Ali Afnan, Ph.D., Process Analytical Technologist, FDA/CDER/OPS

The pharmaceutical industry plays a major role in the lives of individuals by providing critical therapeutic medicines. This places the industry in the public eye, as does drug pricing, safety and efficacy, the stock markets and courting with several different regulatory bodies, with differing legal requirements, around the world. The…

Implementation, validation and registration

20 May 2005 | By Paul J Newby PhD, GlaxoSmithKline R&D

In the last decade interest in Rapid Microbiological Methods (RMMs) has grown considerably. Technologies such as ATP bioluminescence, solid phase laser cytometry and genetic-based identification systems are being vigorously investigated. Validation and regulatory requirements for such new technologies are beginning to emerge. However, there is a lot of confusion and…

The future of process design

20 May 2005 | By Salvatore Mascia, Department of Chemical Engineering, University of Cambridge

Rheology – not to be confused with theology – represents an important and distinctive area of modern engineering science: the ability to specify and control a material's rheology and associated microstructures is a key aspect of many process and product innovations. In the pharmaceutical sector, emulsions and the cohesive wet…

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hoag figure 6

Die-wall stress measurement

20 May 2005 | By Stephen W. Hoag, Ph.D., School of Pharmacy, University of Maryland

Many of the physical factors that affect tablet quality are formed during compaction. Thus, the accurate measurement of tablet compaction will help researchers to better understand compaction and die-wall stress measurements are a critical aspect of being able to measure and understand the three-dimensional nature of compaction.

Ten steps to success

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.

Forging therapeutics from small interfering RNAs

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.

Applications in drug development

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…

A network of innovation from Canada

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…

Evaluating drug safety

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.

New phases for rapid ion analysis

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…

A process analytical tool

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…

Changing the paradigm: Expanding High Content Imaging for early cytotoxicity assessments

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…

Dosing and weighing in the pharmaceutical laboratory

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.

Versatile miniaturised HTS

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…