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Pharma Webinar: Navigating the Complexities of Pharmaceutical Manufacturing Regulations
Pharma Webinar: Navigating the Complexities of Pharmaceutical Manufacturing Regulations

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…

The real-time reverse transcription polymerase chain reaction – treat with caution

21 September 2007 | By Stephen A. Bustin, Academic Department of Surgery, Institute of Cell and Molecular Science, Queen Mary’s School of Medicine and Dentistry, University of London

The real-time reverse transcription polymerase chain reaction (RT-qPCR) has become the enabling technology par excellence in every field of molecular research and development, including that of clinical drug development and discovery. Its ability to detect as well as quantify RNA biomarkers sensitively, specifically and speedily has made it an indispensable…

Maintaining a spore-free environment in the cleanroom

21 September 2007 | By Karen Rossington, Marketing and Development Manager, Shield Medicare Ltd.

The manufacture of sterile pharmaceutical products is governed in the European Union by the requirements of EU Good Manufacturing Practice for Medicinal Products. The GMP guide gives very specific details on the environmental and microbial requirements for aseptic processing. However, little or no guidance is given on how to create…

New trends in intelligent robotics in the laboratory
New trends in intelligent robotics in the laboratory

Protein crystallography in drug design: current bottlenecks

21 September 2007 | By Timothy Allison & Sanjeev Munshi, Department of Structural Biology, Merck, Westpoint, PA

Protein crystallography is an integral component of the structure-guided drug discovery process. Rapid access to structural information about drug targets as well as bound ligands has been pivotal in accelerating lead identification and optimisation processes...

A new era for microcalorimetry in drug development

21 September 2007 | By Dr Ernesto Freire, Faculty Professor, Johns Hopkins University, Baltimore

Drug development involves the identification and subsequent optimisation of low molecular weight compounds with a desired biological activity. Often, the initial binding affinity of those compounds towards their intended target needs to be improved by five or more orders of magnitude before they become viable drug candidates; a process that…

An eight-step Six Sigma toll-gate approach to PAT implementation

21 September 2007 | By Bikash Chatterjee, President of Pharmatech Associates, Inc and Jeremy Green, Senior Consultant for Pharmatech Associates, Inc.

The FDA’s recent guidance regarding Process Analytical Technology (PAT) offers the pharmaceutical and biotech industries an unprecedented opportunity to leverage hard-won experience with scientific inquiry and innovation. However, the leap to PAT is significant for even the most rigorous development program. Many aspects of Six Sigma; including its use of…

Clinical Trials
Clinical Trials

Roundtable: The future direction for clinical trials

21 September 2007 | By

Sally Burtles, Stephen Freestone and Eddie Caffrey discuss the future direction for clinical trials, covering the main challenges faced in the current application of Phase I clinical trials, changes the industry be implementing in order to further improve the efficiency of early clinical trials and how the Regulatory bodies’ guidance…

In vivo drug target validation using RNAi

21 July 2007 | By Jost Seibler, Head of Technology Development, Artemis Pharmaceuticals and Frieder Schwenk, Principal Scientist, University of Applied Science, Department of Applied Natural Sciences, Gelsenkirchen, Germany

Among the genetic model organisms, the laboratory mouse (Mus musculus) has a predominant role in the study of human disease and in pre-clinical drug development. Apart from the high degree of sequence homology of mouse and human genomes, and similarities in many physiological aspects, advanced targeting technologies make the crucial…

How will MicroRNAs affect the drug discovery landscape?

21 July 2007 | By Dr. Neil Clarke and Dr. Mark Edbrooke, GlaxoSmithKline Research and Development, Hertfordshire, UK

The archetypal microRNAs, lin-4 and let-7, were discovered in the nematode worm Caenorhabditis elegans over a decade ago and, at that time, no one would have predicted that they would be anything other than an interesting feature of worm developmental biology. However, in recent years there has been an explosion…