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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…

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…

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…

Academic contribution to high-content screening for functional and chemical genomics

21 July 2007 | By Kerstin Korn and Eberhard Krausz (Corresponding author), Head, HT-Technology Development Studio (TDS), Max Planck Institute of Molecular Cell Biology and Genetics (MPI-CBG)

High-content screening (HCS) is defined as multiplexed functional screening based on imaging multiple markers (e.g. nuclei, mitochondria etc.) in the physiologic context of intact cells by extraction of multicolour fluorescence information1. It is based on a combination of advanced fluorescence-based reagents, modern liquid handling devices, automated imaging systems and data…

The impact of automation on drug discovery

21 July 2007 | By William P. Janzen, President and COO, Amphora Discovery

Automated systems and modern pharmaceuticals have both had a hugely positive impact on human life. While these technologies developed in parallel with one another during roughly the same time period in the early 20th century, they didn’t interact until automation found its way into the laboratory in the 1970s.

Implementation of an enterprise ELN: a case study

21 July 2007 | By Dr. Simon Weston, Programme Delivery Leader, Discovery, AstraZeneca

The paper notebook has played a central role in the recording of the methods and results of scientific research for centuries. It has some strengths: portability, flexibility and (to some degree) incontrovertibility but in an enterprise environment it has many weaknesses. Chief among these is that the vast majority of…

Implementing Near Infrared Spectroscopy as a PAT tool in the biopharmaceutical industries

21 July 2007 | By Payal Roy-Choudhury, PhD Student, Fermentation Centre, Strathclyde Institute of Pharmacy & Biomedical Science, Glasgow, UK

Biopharmaceuticals are the fastest growing sector of the pharmaceutical industry[1]; with monoclonal’s being the key biopharmaceutical products representing a significant proportion of the current business focus. It is anticipated that this new generation of biopharmaceuticals will revolutionise clinical medicine over the next 5-10 years.