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Analytical techniques


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 Steven Doherty, Affiliation: Eli Lilly; Richard Godec, Affiliation: General Electric Analytical Instruments; Matthew Smith, Affiliation: Hach Ultra; Petter Mörée, Affiliation: MKS Umetrics; Ingrid Maes, Affiliation: Siemens; Tony Slapikas, Affiliation: Ametek Process Instruments; Chris Hobbs, Affiliation: ABB

European Pharmaceutical Review presents a comprehensive guide to PAT addressing the challenges and advancements that are impacting upon PAT implementation in 2008 and beyond...

Driving lab automation forward

23 November 2007 | By Dr Gary Allenby, Associate Principal Scientist, Affiliation: Astrazeneca; Professor Gordon Alton, Group Leader, Department of Biochemical Pharmacology, Affiliation: Pfizer; Neil Benn, Head of Automation, Affiliation: Ziath; Mr Kjell Fransson, Senior Scientist, Affiliation: AstraZeneca; Dr Thomas H Keller, Director of Applied Technology, Affiliation: GlaxoSmithKline

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 Dr Anthony Mitchell Davies, Institute of Molecular Medicine, Trinity College Dublin

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 Professor John E. Ladbury, Department of Biochemistry and Molecular Biology, University College London

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…

The future direction of ASTM E55 Committee on manufacture of pharmaceutical products

23 November 2007 | By

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…

Statistical techniques for handling high content screening data

21 September 2007 | By

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…

Protein crystallography in drug design: current bottlenecks

21 September 2007 | By

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

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

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…

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

21 July 2007 | By

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

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.

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