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Issue 3 2013



Screening In-Depth Focus 2013

30 July 2013 | By

In this Screening In-Depth Focus: New approaches to cell based assays for high content screening and analysis; Reduce, reuse, recycle: how drug repositioning is finding its niche in drug discovery; Workshop Review: Biochemical assays for screening. Screening roundtable...


New guidelines for breakmarks on tablets

13 June 2013 | By Tony Moffat, UCL School of Pharmacy and Joint Pharmaceutical Analysis Group

The US Food and Drugs Administration (FDA) produced their guidance for industry on tablet scoring in March 2013 to ensure that tablet scoring (breakmarks or breaklines) on generic tablets would enable them to be split in the same effective way as their reference listed products (RLD).


The Encyclopedia of Rapid Microbiological Methods: The new fourth volume discusses technologies, regulatory acceptance and validation case studies

13 June 2013 | By Michael J. Miller, President, Microbiology Consultants, LLC and

This is the second paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2013. As the editor for the Encyclopedia of Rapid Microbiological Methods, I provide a summary of the latest volume, which was published earlier this year. New case studies,…


Chemometrics: Implementing multivariate data analysis to monitor mammalian cell culture processes

13 June 2013 | By Payal Roychoudhury, formerly AstraZeneca and Ronan O’Kennedy, Fujifilm Diosynth Biotechologies and Jim Faulkner, GlaxoSmithKline and Brian McNeil & Linda M. Harvey, University of Strathclyde

Biopharmaceutical companies are constantly evaluating new methods for mammalian cell line development that offer benefits such as shorter time lines, improved consistency, higher monoclonal antibody (mAb) production, better genetic stability and increased flexibility. Each of these advantages extends a potentially large cost benefit to companies as their recombinant protein products…


Label-free quantitative proteomics: Why has it taken so long to become a mainstream approach?

13 June 2013 | By Thierry Le Bihan, SynthSys and Institute of Structural and Molecular Biology, University of Edinburgh

In recent years, mass spectrometry (MS) based proteomics has moved from being a qualitative tool (used to mainly identify proteins) to a more reliable analysis tool, allowing relative quantitation as well as absolute quantitation of a large number of proteins. However, the developed quantitative methods are either specific for certain…


Isothermal calorimetry in the pharmaceutical sciences

13 June 2013 | By Anthony E. Beezer and Simon Gaisford, UCL School of Pharmacy

Fifty years ago, isothermal microcalorimetry (IMC) was a means to determine thermodynamic data (principally values for enthalpies of formation or reaction to assist in the calculation of Gibb’s Free Energy functions and entropies). These data were used in the compilation of tables of thermodynamic values, for use in evaluating, inter…



13 June 2013 | By Katherine Bakeev, Director of Applications Support, B&W Tek

We talk to Katherine Bakeev, Director of Applications Support, B&W Tek. B&W Tek is a leading supplier of handheld Raman spectroscopy, a recognised method for compliance with the PIC/S GMP guide to provide 100 per cent assurance of the identity of pharmaceutical materials. Katherine Bakeev, Director of Applications Support at…