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Product Quality Lifecycle Implementation (PQLI) – providing practical solutions

23 January 2008 | By

This article discusses ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative, which is to provide practical guidance for implementation of ICH Q8, Q9 and Q10. It represents the author’s individual opinion. It should be noted that PQLI is an evolving work area and so will continue to develop beyond the position…

PAT: a comprehensive guide

23 January 2008 | By

European Pharmaceutical Review presents a comprehensive guide to PAT addressing the challenges and advancements that are impacting upon PAT implementation in 2008 and beyond...

MicroRNAs and their relatives – new avenues in biomedical research

23 November 2007 | By

Non-coding RNAs (ncRNAs) consist of a growing heterogeneous class of transcripts defined as RNA molecules that lack any extensive “Open Reading Frame” (ORF) and function as structural, catalytic or regulatory entities rather than serving as templates for protein synthesis. While non-coding sequences make up only a small fraction of the…

Analysis of microRNA expression by qPCR

23 November 2007 | By

Alteration of microRNA (miRNA) expression in a disease compared to a healthy state and/or correlation of miRNA expression with clinical parameters (like disease progression or therapy response), may indicate that miRNAs can serve as clinically relevant biomarkers1-3. An important first step for further functional characterisation is the information about differential…

Driving lab automation forward

23 November 2007 | By

A round table discussion covering the driving forces behind the integration of automated technology within the pharmaceutical industry, the procedures that are followed when implementing new automated techniques, current areas of drug discovery most benefiting from lab automation, how lab automation advanced the drug discovery marketplace over the last five…

Automated workflow optimisation and assay development strategies for High Content Research Facility, Trinity College Dublin

23 November 2007 | By

High Content Screening (HCS) is becoming increasingly utilised as an early drug-discovery and basic research tool for defining the functions of genes, proteins and other biomolecules in normal and abnormal cellular functions. HCS involves the integration of a number of preparation steps which include; cell-sample preparation, fluorescent labelling, image acquisition,…

Enthalpic efficiency and the role of thermodynamic data in drug development: possibility or a pipeline dream!

23 November 2007 | By

The determination of accurate thermodynamic data for the interactions of biomolecules has been enhanced over the last decade by the use of isothermal titration calorimetric (ITC) instrumentation. These instruments are now standard kits in many biophysical/structural biochemistry laboratories of pharmaceutical companies. Despite this, there is little evidence for the input…

Cutting edge technologies and their potential role in pharmaceutical microbiology

23 November 2007 | By

In order to meet the challenges demanded by the requirements of Process Analytical Technology (PAT), the modern microbiological laboratory needs to become more innovative in microbial detection, identification and enumeration. Technology is becoming available that will speed up microbiological analysis, potentially allowing pharmaceutical microbiology tests to get as close as…

The future direction of ASTM E55 Committee on manufacture of pharmaceutical products

23 November 2007 | By Steve Simmons, Head of Process Knowledge QbD, Wyeth Pharmaceuticals

ASTM Committee E55 formed in April of 2003 as a result of FDA’s GMPs for the 21st Century Initiative and the subsequent Guidance, “PAT – a framework for innovative pharmaceutical manufacturing and quality assurance.” Focusing on process understanding and flexible manufacturing, FDA encouraged the pharmaceutical industry to utilise the consensus…

HVAC energy savings in the pharmaceutical industry

23 November 2007 | By

Proper and compliant HVAC systems are fundamental to the pharma industry as we use high air change rates to secure a low viable and particle contamination. HVAC is energy consuming and therefore the HVAC accounts for a large proportion of the energy used in pharma facilities. In the past the…

The expanding world of small RNA: from germ cells to cancer

21 September 2007 | By Eric A. Miska, The Wellcome Trust/Cancer Research UK Gurdon Institute and Department of Biochemistry, University of Cambridge, Cambridge, UK

Over the last ten years a small RNA revolution has swept biology. In 1998 RNA interference (RNAi) was discovered as an experimental tool by Andy Fire and Craig Mello, a finding that was awarded with the 2006 Nobel Prize for Physiology or Medicine. Although the biology of RNAi is still…

Proteomics – the frontiers and beyond

21 September 2007 | By Walter Kolch, The Beatson Institute for Cancer Research/ Institute for Biomedical and Life Sciences, University of Glasgow

Within a decade proteomics has evolved from a fledgling discipline reserved for specialised laboratories, to a firm fixture in our standard omics arsenal used routinely by the research community. This stunning progress is due to many factors; the finishing of the genome projects provided major intellectual motivation and the development…

Statistical techniques for handling high content screening data

21 September 2007 | By Edward Ainscow, Research Scientist, AstraZeneca

One of the chief incentives for the use of high content screening (HCS) approaches is the data rich return one gets from an individual assay. However, conventional methods for hit selection and activity determination are not well suited to handling multi-parametric data. Tools borrowed from the genomics area have been…

Maximising the efficiency and application of automated planar patch clamp electrophysiology

21 September 2007 | By Paul J Groot-Kormelink PhD, Pamela R Tranter PhD and Martin Gosling PhD, Novartis

The widespread expression of ion channels and their ability to significantly modulate cell function makes them attractive drug targets1. Therapeutic agents which target ion channel proteins comprise the third best selling class of prescription drugs with US sales in 2002 estimated at $12 billion. Somewhat surprisingly the discovery of many…

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