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Issue 4 2011

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eLN supplement 2011

31 August 2011 | By

In this eLN supplement: eLNs - An essential productivity tool - but which one to use?; Using an eLN to create GMP compliant records for drug substance manufacture; Implementation of an electronic lab notebook system at VIB; eLN roundtable...

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Stabilisation of nanoparticles during freeze drying: The difference to proteins

31 August 2011 | By Jakob Beirowski and Henning Gieseler, University of Erlangen-Nuremberg, Division of Pharmaceutics, Freeze Drying Focus Group

The underlying concept for the stabilisation of proteins during freeze drying is the formation of a glassy matrix in which the macromolecules remain isolated and immobilised. The concept relies on the so-called ‘vitrification hypothesis’ which assumes that the formation of an amorphous phase by lyoprotectants is mandatory to interact with…

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Detection of microorganisms using optical spectroscopic-based rapid method technologies

31 August 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the fourth in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2011. Previously, we discussed a number of cellular-component rapid microbiological methods (RMMs), such as ATP bioluminescence, fatty acid analysis, MALDI and SELDI time of flight mass spectrometry, Fourier transform-infrared…

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Inhibition of microbial growth in solid dosages at ICH stability storage conditions

31 August 2011 | By Linda Skowronsky, Senior Microbiologist, GlaxoSmithKline

Several intrinsic and extrinsic factors influence microbial growth. Two important factors include the presence of available moisture and a supportive temperature. The conditions described in ICH Topic Q1A (R2)1 do not allow the organisms of interest in pharmaceutical solids to grow, due to either an unfavourable temperature or humidity. For…

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Implementation of high-throughput quality control processs within compound management

31 August 2011 | By Jerome Giovannoni and J.M. Peltier, Novartis

The constant growth of compound collections, combined with screening efforts on more challenging targets, is creating an increasing demand for quality control in order to ensure the integrity of the compound solutions being tested. This is true throughout the early drug discovery pipeline, from hit identification to lead nomination. Novartis…

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Emergence and identification of new designer drug products from the internet

31 August 2011 | By S. Assi, S. Fergus, J.L. Stair, O. Corazza and F. Schifano, University of Hertfordshire

Designer drugs represent a rapidly expanding phenomenon particularly facilitated by their internet availability. These drugs are continuously emerging as analogues of controlled substances (amfetamine, aminoindane, cathinone, phencyclidine, etc) and once an analogue has been banned, another replacement analogue appears on the market. They are often made in unlicensed laboratories which…

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Thermodynamics and kinetics driving quality in drug discovery

31 August 2011 | By Geoff Holdgate, AstraZeneca

Recently, there has been renewed interest in using thermodynamic and kinetic data, alongside empirical rules (particularly focused upon cLogP and molecular weight) and guiding metrics such as ligand efficiency and lipophilic ligand efficiency developed for fragments, leads and drugs in order to facilitate the design of compounds with a greater…

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Under the microscope: Steve Delity

31 August 2011 | By

Rapid Micro Biosystems is a privately owned, venture backed company with headquarters in Bedford, Massachusetts. Since launching its GrowthDirect™ System in 2008, the company has now moved into Europe with the opening of its new demo centre in Darmstadt, Germany in June 2011. So, how does CEO Steve Delity view…