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Articles

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…

Woman Screening Assay Scientist
Woman Screening Assay Scientist

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.

RNAi: an attractive choice for future therapeutics

23 May 2007 | By John J. Rossi, Division of Molecular Biology, Beckman Research Institute of the City of Hope, Graduate School of Biological Sciences, Duarte, United States

RNA interference (RNAi) is a regulatory mechanism of most eukaryotic cells that uses small double stranded RNA (dsRNA) molecules as triggers to direct homology-dependent control of gene activity (Almeida and Allshire 2005).

Biomarker discovery and validation in clinical proteomics

23 May 2007 | By Professor Stephen R Pennington, Proteome Research Centre, Conway Institute of Biomolecular and Biomedical Sciences, University College Dublin

Until recently the use of proteomics in the biomedical arena has included programmes aimed at the elucidation of cellular responses to extracellular stimuli by known and potential drugs. It has been anticipated that these will lead to the elucidation of the basic mechanisms of cellular responses, potential identification of new…

The handling and analysis of large scale high content screening data

23 May 2007 | By Karol Kozak and Benjamin Eshun, Data Handling in TDS, Max Planck Institute of MolecularCell Biology and Genetics, Germany. Jeff Oegema, CEO, Scionics Computer Innovation, GmbH

Data management has become one of the central issues in High Content Screening (HCS) as it has high potential within predictive toxicity assessments. In particular, HCS applying automated microscopy requires a technology and system which is capable of storing and analying vast amounts of image and numeric data. HCS data…

Launching an HTS campaign to discover new antivirals

23 May 2007 | By Colleen B. Jonsson, Ph.D., Program Leader, Emerging Infectious Disease Research and E. Lucile White, Manager, High-Throughput Screening Center and Enzymology Laboratory, Southern Research Institute, Birmingham, AL, United States

There are over 300 human viruses that have no treatment, vaccine or antiviral. Unfortunately, only sixty-two drugs are approved by the US Food and Drug Administration (FDA) for the treatment of six different viral illnesses. Of these, 45% are for the treatment of HIV/AIDS. The remaining drugs offer treatments that…