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Issue 6 2013

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ICH Q6A specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances

15 December 2013 | By

Specifications (test and acceptance criteria) for active pharmaceutical ingredients (APIs) and drug products are defined in ICH Q6A. It ‘establishes a set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use.’ The guidance is sub-divided into universal tests applicable…

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Laboratory Automation: Liquid handling devices in drug discovery – when, what, why?

15 December 2013 | By Sergio C. Chai, Asli N. Goktug and Taosheng Chen, High Throughput Screening Center, Department of Chemical Biology and Therapeutics, St. Jude Children’s Research Hospital

Liquid handlers are ubiquitous and essential tools in every aspect of the drug discovery arena. Innovations in the past few decades resulted in a sizeable array of devices. With so many choices, it is important to identify appropriate instrumentation for a particular screening strategy, which should be based on unique…

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Pharmaceutical proteomics: a journey from discovery and characterisation of targets to development of high-throughput assays

15 December 2013 | By Joerg Reinders, Institute of Functional Genomics, University of Regensburg

Proteomics has evolved during the last few years from a time-intensive, cost-intensive and hard-to-reproduce technique in basic research to a versatile and reliable tool in various areas of pharmaceutical research. The exploding progress in mass-spectrometry-compatible protein and peptide-separation methods led to the development of new approaches particularly suited for monitoring…

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Next generation sequencing: Application of next generation sequencing to preclinical cancer model profiling

15 December 2013 | By

Preclinical cancer models allow us to gain insight into therapeutic potential and mechanism of anti-cancer agents early in the drug discovery process. Whilst traditional array-based approaches have made a significant contribution to the characterisation of these models, the advent of next generation sequencing has revolutionised genomic research and is anticipated…

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Microbiology: Mould contamination in pharmaceutical drug products and medical devices

15 December 2013 | By

Invasive fungal infections associated with high mortality rates are common in hospital settings, especially in intensive care units where patients may be immune-compromised, subject to invasive procedures and treated aggressively with antibiotics. The most common nosocomial fungal infections in descending order are due to the genera Candida, Aspergillus, Rhizopus, Fusarium…

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Process systems engineering (PSE) in the pharmaceutical industry: past and future

15 December 2013 | By Christos Georgakis, Department of Chemical and Biological Engineering and Systems Research Institute for Chemical and Biological Processes, Tufts University and Gregory M. Troup, Merck Research Laboratories, Merck & Co., Inc

Process Systems Engineering (PSE) has had a profound impact in the chemical, petroleum and petrochemical industry in the last 30 - 40 years. Even though PSE has already started to make a significant impact on the pharmaceutical industry, there are substantial additional benefits that can be derived. The purpose of…

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Next generation sequencing: Using RNAseq to identify anti-cancer targets in the tumour vasculature

15 December 2013 | By Klarke M. Sample and Roy Bicknell, University of Birmingham

It is possible to attack the vasculature within solid tumours and achieve an anti-cancer effect. In the last decade, a number of studies have utilised cDNA libraries, SAGE analysis and microarrays to identify potential drug targets in the tumour endothelium. Modern sequencing technologies are likely to be a far more…