Analytical techniques

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

23 November 2007 | By Steve Simmons, Head of Process Knowledge QbD, Wyeth Pharmaceuticals

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…

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Statistical techniques for handling high content screening data

21 September 2007 | By Edward Ainscow, Research Scientist, AstraZeneca

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…

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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...

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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…

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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…

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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…

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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.

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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.

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A “PAT” on the back for Rapid Microbiological Methods

21 July 2007 | By Robert Johnson, Director, Dialogue

The modern microbiological laboratory needs to change and become more innovative in its approach to microbial detection, enumeration and identification.

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Process Analytical Technologies (PAT) in the pharmaceutical industry

21 July 2007 | By European Pharmaceutical Review

European Pharmaceutical Review brings you a comprehensive guide to the current developments and possible future innovations within Process Analytical Technologies...

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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…

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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…

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Calorimetry for amorphous content quantification

23 May 2007 | By Simon Gaisford PhD and Rita Ramos PhD, School of Pharmacy, University of London

In the previous article (European Pharmaceutical Review, Issue 2, 2007) an introduction to calorimetry was given and its application to polymorph characterisation, discussed. Another area of application of growing importance is quantification of (usually small) amorphous contents. A requirement to demonstrate the presence or absence of amorphous material is becoming…

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Automated classification of crystallisation images

23 May 2007 | By Julie Wilson, York Structural Biology Laboratory, Department of Chemistry, University of Heslington, York, UK

The findings of many crystallisation experiments are required in order to identify conditions that will produce diffraction quality crystals. The use of robots has increased the number of experiments performed in most laboratories and, in structural genomics centres, tens of thousands of experiments can be produced every day. As each…

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PAT and design science

23 May 2007 | By Carl-Fredrik Mandenius, Micael Derelöv, Jonas Detterfelt, Mats Björkman, Division of Biotechnology/IFM and Division of Production Systems/IKP, Linköping University, Sweden

Process analytical technology (PAT) and mechanical design science are interconnected; this article describes how a well-established design modelling approach; the Hubka-Eder model, is applied to the concepts of PAT and quality by design (QBD). The model connects PAT with quality management concepts as defined for PAT by the ICH guidelines…