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PAT: not a purpose in itself

19 March 2008 | By

The process analytical technology guidelines have been a hotly debated topic within the pharmaceutical industry ever since they were made public in 2004. This also holds true at Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), Division of Janssen Pharmaceutical N.V. In recent years, the company has introduced PAT tools…

Genome-wide High Content Analysis of cellular pathways

23 January 2008 | By

Creating the molecular tools to combat human disease and infection remains the cornerstone activity of the pharmaceutical industry. The methodologies employed to discover new drugs has continually evolved as new biological techniques have emerged1; nevertheless the development of each novel compound is still only realised after many years of careful…

High throughput materials discovery “reducing product time to market”

23 January 2008 | By Dr. Neil Campbell, Senior Experimental Officer, Automation and Process Development Specialist, Centre for Materials Discovery, University of Liverpool

With ever mounting market pressure on industries, from increasing global competition, along with consumer desire for value for money and improved performance results there is a greater driving force to stay one step ahead by reducing product time to market. This enforced impetus has many companies having to continually improve…

Microbiology / Microbiologists – Where next?

23 January 2008 | By Stewart Green Director of Quality, Wyeth, UK and Chair, Pharmig

Arguably microbiology is the oldest of the applied sciences, although early exponents doubtless had no understanding of how the fruits of their labour in fermentation for example, came about. The true forerunners of microbiology as it is recognised today would be Koch, Pasteur, Petri et al, who developed much of…

Trends in pharmaceutical cleanroom technology

23 January 2008 | By Hans H. Schicht, Dr. sc. Techn, Dr. Hans Schicht Ltd

There are many trends worth reporting in the context of pharmaceutical cleanroom technology: technical as well as regulatory trends. Supporting them is the continuing trend towards worldwide international standards, not only regarding contamination and biocontamination technology, but also regarding related topics such as air filtration. The endeavours for controlling micro-organisms,…

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…

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