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20 July 2006 | By Tim Lloyd, Editor, European Pharmaceutical Review
Rapid microbiology is an exciting field for the development of new technologies and applications. There are significant challenges to be overcome and in doing so, great prospects for microbiologists and the companies that provide cutting-edge equipment.
24 March 2006 | By Cees Gooijer, Freek Ariese and Reyer J. Dijkstra, Dept. of Analytical Chemistry and Applied Spectroscopy, Laser Centre Vrije Universiteit
Currently, Raman spectroscopy (RS) is rapidly becoming a mature analytical technique in the pharmaceutical world. Thus far, it is used almost exclusively in a stand-alone mode, since coupling with liquid separation methods hardly seemed realistic in practice. However, as outlined in this article, recent developments are quite promising and such…
24 March 2006 | By Bengt Ljungqvist, Ph.D. and Berit Reinmüller, Ph.D. KTH Stockholm
To verify that cleanroom and clean zones are adequately installed and functioning they are usually validated during three occupancy states. First, when the installation is complete with all services connected and functioning, as-built; secondly during at-rest conditions when equipment is installed and running in a manner agreed upon by customer…
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).
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.
22 August 2005 | By Marleen de Veij, Dr. Peter Vandenabeele and Prof. Dr. Luc Moens, Laboratory of Analytical Chemistry, Ghent University
Traditionally, analyses in pharmaceutical research and industry were often performed using Nuclear Magnetic Resonance (NMR) or Mass Spectrometry (MS). However, researchers are aware that Raman Spectroscopy possesses advantageous characteristics for the pharmaceutical world.
22 August 2005 | By Dr Hans H. Schicht, Dr. sc. techn., Dr. Hans Schicht Ltd. Contamination Control Consulting
Regulatory guidance documents, such as Annex 1 to the GMP guideline of the European Union1 and FDA's comparable Guidance for Industry2 establish the objectives to be met by pharmaceutical contamination control systems – especially those for the production of sterile medicinal drugs.
20 May 2005 | By Bernhard Schrader, Institut für Physikalische und Theoretische Chemie, Universität Duisburg-Essen and Hartwig Schulz, Federal Centre for Breeding Research on Cultivated Plants, Institute of Plant Analysis
Raman spectroscopy using excitation in the near infrared allows non-destructive Raman analyses of pharmaceutical products as well as of plant or animal tissues. This radiation excites only minimal fluorescence of the samples or impurities and has only minimal photo-physical and photochemical activity. Raman analysis of plants allows the efficient exploration…
7 March 2005 | By Dr. Ulrich Schopfer, Global Head of Compound Management, Dr. Frank Hoehn, Laboratory Head, Automation, Matthieu Hueber, Automation Engineer, Novartis Institutes for BioMedical Research
Dispensing of solids is still a demanding task in laboratory automation. The solubilisation of High Throughput Screening (HTS) libraries is one of the most challenging problems in this area, since millions of different substances have to be processed by the same technology.
