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19 June 2008 | By
European Pharmaceutical Review has brought together four individuals from different sides of the scientific palette to discuss current and future issues surrounding secondary screening and maximising its potential.
19 June 2008 | By
Drug discovery relies on massive screening of compound libraries with in vitro cell-based target assays. These pharmacological screens have been well accepted. For in vitro toxicological screening, this privilege has only been obtained for the Ames, chromosomal aberration and eye irritation tests. At the moment, a number of cellular assays…
19 June 2008 | By Dr Stefan Przyborski, Chief Scientific Officer, ReInnervate Ltd, School of Biological and Biomedical Science, Durham University
Cell culture assays play an important role during the first stages of pharmaceutical development. The design of such in vitro models is significant and data resulting from such tests directly influences the progression of compound development. Therefore it is becoming progressively more important to design cell culture assays that are…
19 June 2008 | By
Recombinant human interleukin-eleven (rhIL-11) is a pleiotropic cytokine which stimulates stem cell proliferation and affects multiple cell types1. The protein has been demonstrated to provide clinical benefit in platelet restoration2 and Crohn’s disease3. rhIL-11 is a highly basic protein that is rich in arginine, leucine and proline residues, lacks disulfide…
19 June 2008 | By
Siemens seeks to deliver breakthrough innovations to give customers a unique competitive edge, in turn enabling societies to master their most vital challenges and creating sustainable value. Siemens was one of the first suppliers to adopt the new guidelines of the Food & Drug Administration (FDA) and the European Agency…
19 June 2008 | By Serguei Tchessalov and Nicholas Warne, Wyeth BioPharma, Andover
During the past 10-15 years, close attention has been paid to the development of optimal lyophilization cycles for different types of pharmaceuticals1-4. Recent advances in process control, such as the Smart Freeze-DryerTM technology or similar approaches, [5-7] make cycle development a routine procedure. The attention of many researchers has shifted…
19 June 2008 | By Graham Cook PhD, Senior Director, Process Knowledge/Quality by Design, Wyeth Pharmaceuticals
In June 2006, the EMEA called for nominations from companies to participate in the pilot phase of a worksharing exercise for Quality variations1. Worksharing is a key element in the revisions to the variations proposed by the European Commission, which are intended to streamline the process for making changes to…
19 June 2008 | By
PAT implementation gurus’ Expo Technologies talks to European Pharmaceutical Review about PAT and why they are at the top of their game.
19 June 2008 | By
MicroRNAs (miRNAs) are a class of small non-coding RNA molecules, which are potent post-transcriptional gene expression regulators. They have been shown to participate in the regulation of numerous cellular processes, the list of which is still growing. miRNAs affect numerous targets that can be determined by direct experiments or predicted…
19 June 2008 | By
The ease in making process analytical measurements (typically spectroscopic) in manufacturing has provided a unique opportunity to obtain up-to-date information for making timely process correction decisions. At-line methods provide near-time information without the need for elaborate process control interfacing upfront. This approach works well for batch processing applications or unit…
19 June 2008 | By
Over the last decade, interest in rapid microbiological methods (RMMs) in the pharmaceutical sector has grown considerably. Technologies such as ATP bioluminescence, solid phase laser cytometry and genetic-based identification systems are being vigorously investigated. Validation and regulatory requirements for such new technologies are beginning to emerge. However, there is a…
7 April 2008 | By
There has been much interest in the promise of proteomics to deliver biomarkers with utility for disease diagnosis and classification, and for assessing therapeutic efficacy and monitoring disease progression. However recently, particularly in the past year, expressions of concern have started to emerge regarding the paucity of protein biomarkers that…
7 April 2008 | By
One of the most profound advances in biology and medicine has been the sequencing of entire genomes, including the human genome. The end product was the availability of the complete genetic blue print of organisms of importance to medicine and biotechnology. This changed how we conducted science. Cloning individual genes…
7 April 2008 | By
Laboratory automation development is being increasingly outsourced to the commercial market according to a recent industrial member survey by the Association for Laboratory Automation (ALA). ALA polled 400 of its members in industry with 14 questions and received 72 responses representing 47 different companies in the Pharma, Biotech and Agriculture…
7 April 2008 | By
Recent years have seen great upward leaps in the development of mass spectrometry applied to the field of proteomics. Today it is possible to take a complex biological sample such as organelles, cells, tissue or a biofluid, perturbed or stimulated in some way, and identify and quantitate up to several…
