Analytical techniques

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Calorimetry for polymorph detection

27 March 2007 | By Simon Gaisford PhD., School of Pharmacy, University of London and Michael AA O’Neill PhD., Department of Pharmacy and Pharmacology, University of Bath

Characterising the properties of a material, understanding how these properties change in relation to local environment and quantifying potential interactions with other species are facets central to any drug development programme. Not understanding and, more importantly, not controlling these factors can have serious consequences for a pharmaceutical, from irreproducible processing…

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PAT and scalable automation for bioprocess control and monitoring

27 March 2007 | By Joydeep Ganguly, PAT Group Lead and Gerrit Vogel, Senior Engineering Manager, Talecris Biotherapeutics

This case study provides a comprehensive look at Talecris1 Biotherapeutics’ approach to PAT and automation followed by examples of PAT deployed on a bioprocess. It introduces the concept of integrated and scalable automation, provides a comparison of automation concepts and explains how the selected automation effectively supports initiatives such as…

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HCS roundtable; Achieving the potential of HCS

25 January 2007 | By EPR

Introducing the Panel...

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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…

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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…

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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.

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The role of HTS in eADMET profiling

28 September 2006 | By Werner Stuermer, Altana Pharma

Historically (until the late 1980s), compounds discovered by phenotypical in vivo screens were at least characterised with implicit ADMET data. An attractive compound in these test systems was available at the (usually unknown) target; had a minimal toxicological profile (the animal did not die immediately) and gave phenotypical (High-Content) information…

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Wyeth forges ahead

28 September 2006 | By Graham Cook Ph.D., Director Technology and External Supply, EMEA, Wyeth

Is the pharmaceutical manufacturing environment of today becoming more challenging? There is increasing pressure to control or reduce costs because of the limitations on healthcare budgets. Asset utilisation, operating efficiencies and cycle times in the pharmaceutical industry generally compare unfavourably with other high technology industries. Despite the resources invested in…

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Streamlining with automation and robotics

28 September 2006 | By Bart Hazes, Dept. of Medical Microbiology & Immunology, University of Alberta and Bernhard Rupp, q.e.d. life science discoveries, inc.

Protein crystallography has been embraced by the pharmaceutical industry to accelerate and rationalise the drug development process. In this role, success rates, throughput and turnaround times have become key competitive factors, and nearly every stage in the protein crystallography process has been targeted for automation using robotics and advanced software.…

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Essential techniques for development

28 September 2006 | By Dr Danielle Giron, President, Swiss Society for Thermal Analysis & Calorimetry

Thermal analysis methods and coupled techniques are well established procedures in material science. Due to the different information delivered, thermal analysis methods are concurrent or complementary to other analytical techniques such as spectroscopy, chromatography, melting point determination, loss on drying, assay, for identification, purity and quantitation. They are basic methods…

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Affinity-based screening

20 July 2006 | By Dr Lorenz M. Mayr, Executive Director & Head Biochemical Screening and Dr Hartmut Zehender, Labhead SpeedScreen, Biochemical Screening, Novartis Institute for Biomedical Research

Drug (lead) discovery relies on massive screening of chemical libraries against various extra- and intracellular molecular targets to find compounds with the desired mode of action. Sequencing of the human genome1 has generated a large number (>40 per cent) of new molecular targets with unknown function (‘orphan targets’), as well…

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Identifying human toxicity potential

20 July 2006 | By Dolores Diaz, CEREP and Peter J. O’Brien, Safety Sciences Europe, Pfizer Global R&D

The statins (3-hydroxy-3-methylglutaryl coenzyme A [HMG-CoA] reductase inhibitors) are drugs that inhibit cholesterol biosynthesis by blocking the formation of the cholesterol precursor mevalonate. Statins are the most effective cholesterol-lowering agents available and are considered the first line of treatment for most patients with high serum cholesterol levels1.

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The business benefits

20 July 2006 | By Jean-Marie Geoffroy, Ph.D., Director, Pharmaceutical Development, TAP Pharmaceuticals, Inc.

So far in 2006 we have published contributions on a variety of PAT-related topics, including training (Issue 1), NIR (Issue 2) and the role of PAT in biotechnology (Issue 3). In this article Jean-Marie Geoffroy reports on the business case for PAT with his own interpretation and charts the road…

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Structural genomics, the practical way

20 July 2006 | By Frank von Delft, Principle Investigator, Protein Crystallography Group, Structural Genomics Consortium, University of Oxford

The Structural Genomics Consortium (SGC) is an internationally funded collaboration with sites in three countries and a three-year goal of solving the 3-dimensional structures of more than 380 human proteins with particular medical relevance, and placing them in the public domain without restrictions. The structures should prove an invaluable resource…

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SCTA for pharma

20 July 2006 | By Prof. P. A. Barnes, School of Applied Sciences, Prof. E. L. Charsley, Head of the Centre for Thermal Studies and Dr G. M. B. Parkes, Senior Lecturer in Analytical Science, University of Huddersfield

The determination of the key physical and chemical properties of a new material is essential. The melting point, glass transition temperature, the number and identification of the different phases it may have, and the temperatures at which they are formed are all of great value, not only in assessing its…