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Cost, knowledge and convenience: facing the facts

2 February 2006 | By Professor David Littlejohn, Head of the Department of Pure and Applied Chemistry at the University of Strathclyde, Director of CPACT at the University of Strathclyde

There can be no doubt that the FDA’s initiative on Process Analytical Technologies (PAT) has had an enormous impact on the pharmaceutical industries. However, the emergence of ’born again‘ PAT devotees in pharma companies has caused mild amusement in other industries where on-line analysis has been an integral part of…

Setting new standards in Ultra HTS

2 February 2006 | By Elisabeth Pook, Stefan Martin Mundt, Adrian Tersteegen, Department of Cardiovascular Research, Pharma Research Center Wuppertal, Bayer HealthCare AG

Ultra high-throughput screening (UHTS) offers the possibility to discover novel pharmacophores. To benefit from UHTS special demands concerning assay quality and data analysis have to be met.

In vitro safety pharmacology profiling

2 February 2006 | By Jacques Hamon, Kamal Azzaoui, Steven Whitebread, Laszlo Urban, Edgar Jacoby, Bernard Faller, Novartis Institutes for BioMedical Research

One major cause of the late failure of drugs in development (i.e. attrition) is the lack of clinical safety of the compounds (accounting for approximately 30% of failures together with toxicology)1. One of the key elements is the off-target effects of the compounds, causing adverse drug reaction (ADRs).

Opportunities for Rapid Microbial Methods

2 February 2006 | By Anthony M. Cundell, Ph.D. Consulting Microbiologist

Since the 2000 publication of the PDA Technical Report Number 33 Testing Methods, rapid microbial methods (RMM) have not lived up to their promise for changing routine Quality Control microbiological testing in the pharmaceutical industry. With the next generation of rapid microbial methods emerging from the R&D laboratories of instrument…

Making the lab workhorse run faster

2 February 2006 | By Holly Hilton, Ph.D. and Charu Kanwal Ph.D. Research Informatics, Genetics and Genomics Hoffmann La-Roche Inc.

Quantitative real-time PCR, the workhorse of any genomics lab, is a well established technique that has numerous uses due to its simplicity and flexibility. In this article we will review a brief history of real time PCR, discuss our strategy for optimising a lab running Quantitative-RT-PCR and describe how this…

Tool for candidate drug selection

2 February 2006 | By Anders Grahnén, Ph.D.,Professor of Clinical Drug Development Sciences, Uppsala University; Chief Scientific Officer, Quintiles Nordic Region

Utilising man as a species for candidate drug selection is per se not a new concept, but the development of new technologies have made it possible to be realised in practice.

Applications in target ID and validation

11 November 2005 | By Oliver C. Steinbach, Head of Department, Technology Management, ALTANA Pharma AG

RNAi technology provides the ‘loss of function’ approach, which has been widely used in the last couple of years for analysis of gene function, and in drug discovery for identification and validation of potential drug target candidates. This technology is now widely applied for functional screens in order to identify…

Meeting the challenge with a new facility

11 November 2005 | By EPR

The conclusion of the Genome Sequencing Project – far from providing the solution to the problem of human disease – has created further questions that had not previously been considered. Hence, the age of genomics has initiated the need to examine the body’s real biochemical actors: proteins, to learn about…

Options for quantitative analysis by real-time PCR

11 November 2005 | By Gareth Elvidge, PhD, Genomics Group, Wellcome Trust Centre for Human Genetics, University of Oxford

The expansion of microarray-based gene expression studies has led to an increase in demand for gene-specific PCR-based methods for independent validation of results. Although a number of technologies are available to meet this requirement the most popular is currently real-time PCR.

A new approach to ion channel hit identification

11 November 2005 | By Martin J. Main, Karen Jones, Biological Chemistry, AstraZeneca R&D, UK, Mats A. Svensson, Dirk Weigelt and Markus Haeberlein, Chemistry, AstraZeneca R&D, Sweden

Advances in assay technology are driving an exciting new era in ion channel drug discovery. Here, we present a case study describing the use of computational chemistry and focussed library screening to drive rapid hit identification.

A bright future for drug discovery and development

11 November 2005 | By Dr Frank Straube, Biomarker Expert, Novartis Pharma AG

High content imaging (HCI), the combination of automated fluorescence microscopy with quantitative image analysis, has been opening new dimensions in cytometry. This article gives an overview on the growing spectrum of applications and an outlook on the future use of this still rapidly developing technology.

Mass Spectrometry: another tool from the PAT toolbox

11 November 2005 | By Steve Doherty and Aaron Garrett, Manufacturing Science and Technology, Mark LaPack, Process Research and Development, Eli Lilly and Co.

Optical techniques can not address every application need, so the well-equipped PAT toolbox must include a broad array of technologies. One analytical tool that has been less-published but no less useful than the optical methods is mass spectrometry. This article provides a brief review of some of the published uses…

Applications in bioprocesses and biotechnology

11 November 2005 | By ,

Raman spectroscopy is a highly versatile tool that provides chemical fingerprints from biological material that can be interpreted using chemometrics and machine learning. In combination this powerful approach is being developed for the quantitative determination of multiple determinands in bioprocesses and for the characterisation of microorganisms.

Why is thermal analysis important to the industry?

11 November 2005 | By Dr Paul G. Royall, Lecturer in Pharmaceutics, School of Chemical Sciences & Pharmacy University of East Anglia, See-wah Jai Tang, Pharmaceutical Science Research Division, King’s College London

Thermal analysis equipment can be found in nearly all of the analytical, development, formulation and QA laboratories within the pharmaceutical industry. However, these work horse instruments are learning to run faster and to analyse an ever more varied field of samples.

The current state of PAT in freeze drying

11 November 2005 | By Michael Wiggenhorn, Gerhard Winter, Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, Ludwig-Maximilians-University and Ingo Presser, Boehringer Ingelheim

Freeze drying is a widely used method to stabilise protein pharmaceuticals. The stability of proteins and the biological activity can be influenced by several factors, which may lead to conformational changes and to denaturation, aggregation or absorption to surfaces1.