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New opportunities for protein crystallisation

25 January 2007 | By EPR

In a previous article the important role of protein crystallography in the optimisation of drug candidates was highlighted1. An essential part of this process is establishing robust protein crystallisation systems that can be used for both soaking and co-crystallisation experiments. This may mean producing many hundreds of X-ray quality crystals…

Real-time PCR gene expression profiling

25 January 2007 | By Mikael Kubista, TATAA Biocenter and MultiD Analyses AB, Sweden, Björn Sjögreen, Center for Applied Scientific Computing, Lawrence Livermore National Laboratory, United States and MultiD Analyses AB, Amin Forootan, MultiD Analyses AB, Radek Sindelka and Jiri Jonák, Laboratory of Gene Expression, Institute of Molecular Genetics, Academy of Sciences of the Czech Republic and José Manuel Andrade, Dept of Analytical Chemistry, University of A Coruna, Spain

Real-time PCR has rapidly become the preferred technique for quantitative analysis of nucleic acids. Its superior sensitivity, reproducibility and dynamic range make it the preferred choice for expression profiling in scientific, as well as routine, applications.

PAT for freeze drying: cycle optimisation in the laboratory

25 January 2007 | By Dr. Henning Gieseler, PhD., Department of Pharmaceutics, University of Erlangen-Nuremberg

Freeze drying is generally known to be a time consuming and therefore expensive process. In order to lower costs during manufacturing, the effective cycle time must be reduced. This goal can be achieved by optimising a freeze drying cycle in the laboratory – in particular the primary drying phase. Applying…

PAT for the product lifecycle of a biopharmaceutical product

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…

Are the needs of the pharmaceutical industry being met?

25 January 2007 | By Dr Andrew M. Middleton, GlaxoSmithKline

Subsequent to the publication of the PDA technical Report Number 33 in 20001 there has been a multitude of articles published in pharmaceutical reviews and commentaries with regard to rapid microbial methods (RMM). The majority of these articles cover, to a greater or lesser degree, the technologies available and summaries…

Challenges in High-Content siRNA Screening

28 November 2006 | By Dr. Eberhard Krausz, HT-Technology Development Studio (TDS), Max Planck Institute of Molecular Cell Biology and Genetics (MPI-CBG)

Huge progress has been made, both in RNA interference technology applied to mammalian cells and in automated microscopy to analyse gene functions upon silencing in the cellular context. Large-scale siRNA screens have been published recently, mainly applying assays that gain multi-parametric information on biological processes. It is a long way…

HUPO drives the creation of protein test standards

28 November 2006 | By John R. Yates, III, Department of Cell Biology, The Scripps Research Institute, Thierry Rabilloud, DBMS/BMCC, Alexander W. Bell, Montreal Proteomics Centre, McGill University and John J. M. Bergeron, Department of Anatomy and Cell Biology, McGill University, Quebec

Over the last ten years the Proteomics field has been a technologically dynamic area. New methods and techniques help drive the field to achieve more sophisticated measurements that yield increasingly larger volumes of data and information. This creates several problems.

Industry Insight: The measure of success

28 November 2006 | By EPR

“Getting to results faster and with higher data quality are challenges for major techniques, especially separation techniques such as LC and LC/MS.” explains Jaquemar. “Equally, solutions for secure information management are rapidly gaining in importance.”

Designing a program for early CNS development

28 November 2006 | By Irina Antonijevic, Douglas Craig and Christophe Gerald, Lundbeck Research USA, Inc.

Only a few innovations have been made in recent decades with regard to psychiatric, and particularly antidepressant, drugs (Insel et al., 2006) (Figure 1). This conundrum reflects, at least partly, the lack of understanding of the disease biology. This poses a challenge not only to inventive drug development, but also…

Pursuing hot targets in drug discovery

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…

A roadmap for development

28 November 2006 | By EPR

Laboratory automation in pharmaceutical research is an established technology, but what does the future hold for its role in R&D? European Pharmaceutical Review asked four industry experts for their views, and you can read what they had to say in this virtual round table discussion.

Is the dream becoming reality?

28 November 2006 | By Andy Chang and Jean-Philippe Stephan Ph.D., Assay and Automation Technology department, Genentech, Inc

During the last decade, technical developments have dramatically changed the way cell-based assays could be implemented and used in research and development organisations. Although cell-based assays have moved into a modern era, cells are still grown and maintained in the same way as decades ago; i.e. manually. However, automation systems…

Polyphasic approach to microbial identification

28 November 2006 | By Hans-Joachim Anders, Marion Keller, Manfred Berchtold and Werner Hecker, Novartis Pharma Stein AG, Biological and Microbiological Services, Switzerland

The identification of microorganisms from the pharmaceutical production environment has gained an ever greater importance in modern times. Thus the new Aseptic Processing Guide of the FDA recommends the identification of detected isolates from the critical clean room area (grade A or ISO 5) down to the species level and…

Committee E55 – an update

28 November 2006 | By Pat Picariello, Director of Developmental Operations, ASTM International

Since its creation in December 2003, ASTM International Committee E55 on Manufacture of Pharmaceutical Products has grown in size as well as global relevance. Recent liaison relationships have been established with the ISPE and the European Compliance Academy (ECA) regarding their internal distribution of E55 draft standards for the purpose…

The right approach to human therapy

28 September 2006 | By Dr Simone Hess, Max-Planck-Institute for Infection Biology

The RIGHT (RNA Interference Technology as Human Therapeutic Tool) consortium consists of 18 research institutions and four companies from nine European countries. The project has been funded as an integrated project by the European Commission’s Sixth Framework Programme for Research and Development (FP6) since January 2005. Thomas F. Meyer from…