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Issue 5 2009
Issue 5 2009 / 9 October 2009 /
The increasing number and diversity of traditional patient therapies, medical devices, and combinatorial products has created an increasing world-wide interest in the innovation of novel sterilisation technologies. In contrast to traditional moist heat sterilisation processes, emerging technologies are diverse, predominantly reliant on physical processes, involve multiple mechanisms of microbial inactivation and span the complete electromagnetic spectrum. New and emerging technologies include high hydrostatic pressures, pulsed electric fields and low-temperature plasmas that accomplish expedient inactivation of microorganisms at ambient or moderately elevated temperatures. This review presents a high level overview of novel, emerging and developing sterilisation technologies with particular focus upon two potential winners in the race to novel, non-traditional commercially viable modes of sterilisation. (more…)
Tagged with: Ash Khorzad, Baxter Healthcare, Edward Tidswell, Microbiology, Mike Sadowski
Issue 5 2009 / 9 October 2009 /
A multitude of novel therapeutic antibody formats based on modification of the conventional IgG format have arisen in recent years. The intensification of interest in this area reflects a pressing need for an additional repertoire of therapeutic molecules which retain the exquisite binding specificity and low intrinsic toxicity of monoclonal antibodies (mAbs), while engineering additional features which enhance clinical efficacy, for example, by improving tissue perfusion or demonstrating increased specificity for a defined cell type. This article briefly reviews the key molecular aspects of therapeutic antibody fragments in development, including single-chain Fv fragments (scFvs), camelid VHH domains, human domain antibodies (dAbs), and an expanding array of bispecific/dual-targeting variants. Such molecules, characterised by unique biophysical and pharmacological properties, are ideally placed to become the next generation of antibody-based therapeutics. (more…)
Tagged with: GlaxoSmithKline, GSK, Martin Scott, Neil Clarke
Issue 5 2009 / 9 October 2009 /
For three days the halls will be alive with exhibitors and visiting professionals from all over the world, together with distinguished speakers and investors – all to discuss the latest products, innovations, research findings and market opportunities. (more…)
Tagged with: Biotechnica, Show Preview
Issue 5 2009 / 9 October 2009 /
A wide and versatile range of analytical techniques are routinely used, indeed are necessary, in pharmaceutical analysis. Over the past decade Raman spectroscopy has increasingly come to the fore as a valuable member of the arsenal of methods used, from both a fundamental and applied perspective, for the interrogation of solid, liquid and solution phase samples. Advances have occurred not only in instrumentation but also in fundamental techniques and applications. The method holds substantial potential for the investigation of, what are normally considered, problematic or challenging areas of analysis. The aforementioned areas include – but are, definitely not limited too reaction kinetics, pharmaceutical drug discovery, detection of counterfeit/adulterated/illegal drugs, trace analysis and uses for on-line pharmaceutical process manufacturing. This, the first of several articles on the use of Raman spectroscopic techniques in pharmaceutical analysis, provides an introductory overview of the theory of the technique. (more…)
Tagged with: Babur Z. Chowdhry, Bruce Alexander, Raman Spectroscopy, Saima Jabeen, University of Greenwich
Issue 5 2009 / 9 October 2009 /
Pharmacodynamic biomarkers in drug discovery: Developing a new drug is an expensive and time-consuming business1-3. A substantial part of the overall cost of drug development is the investment in molecules that fails at some point during the development process and it is necessary to identify these compounds as early as possible. Several different approaches are being pursued across the pharmaceutical industry to reduce the high attrition rates. One of these approaches is to identify biomarkers that are predictive of safety or efficacy and can be used in early clinical trials to build confidence that the molecule is engaging the intended target and is therefore worth investing more resources on4. (more…)
Tagged with: Biomarkers, Magnus Ivarsson, Pfizer
Issue 5 2009 / 9 October 2009 /
The ELRIG Forum 2009 is organised in cooperation with the European ScreeningPort and the North German life science agency Norgenta. (more…)
Tagged with: ELRIG, Show Preview
Issue 5 2009 / 9 October 2009 /
A pivotal attraction of qPCR technology is its apparent lack of complication; an assay consisting of the simple procedure of combining oligonucleotides, PCR mastermix buffer and nucleic acid template to produce a qPCR reaction is perceived as undemanding. This practical simplicity is complemented by the absence of any requirement for post-assay handling, as well as the development of user-friendly data analysis software that makes data generation and visualisation in the shape of amplification plots remarkably simple. However, as we have set out in the first four articles of this series, the translation of an attractive amplification plot into accurate and meaningful data is far from trivial and requires a range of additional considerations. (more…)
Tagged with: Jim Huggett, LGC, qPCR, Sigma-Aldrich, Stephen Bustin, Tania Nolan
Issue 5 2009 / 9 October 2009 /
Process analytical technology (PAT) initiatives are now an integral part of developmental efforts in the pharmaceutical industry. Many technical and scientific papers and even dedicated sections appear regularly in several pharmaceutical manufacturing publications. They may be part of a quality by design (QbD) project to better identify and understand critical process parameters. The need and plus value of PAT is usually well-recognised and understood through establishment of the design space of a unit process. However, monitoring and control methodology and PAT protocols are still undefined, and there is no global consensus yet. It is on these grounds that ASTM started working groups focusing on the elaboration of standards in model building and process monitoring with PAT. (more…)
Tagged with: Jean-Sébastien Simard, Nicolas Abatzoglou, PAT, Pierre-Philippe Lapointe-Garant, Wyeth
Issue 5 2009 / 9 October 2009 /
The conference in October 2008 marked some dramatic changes for MipTec: Most notable was the policy of free registration for the conference and exhibits. This drew a record attendance for the 12 years of the conference with more than 2,300 attendees. It was so successful that free registration will be continued for 2009. Changes are also in place for 2009, including additional session chairs, renowned experts in their fields, to bring new ideas to the drug discovery themes. A new session on biopharmaceuticals will ensure the scientific program stays current, while updating and improving established sessions will ensure that these important topics continue to be leading edge. Whether you are an academic scientist, a researcher in a pharmaceutical or biotech company or a developer and supplier of technology, this is the conference that should not be missed. (more…)
Tagged with: MipTec, Show Preview
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