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Issue 5 2009

 

Dr Edward Tidswell
Dr Edward Tidswell
article

Novel and emerging sterilisation technologies

9 October 2009 | By Dr Edward Tidswell, Senior Director of Sterility Assurance, Baxter Healthcare; Ash Khorzad, Sterile Manufacturing Support Group Manager and Mike Sadowski, Director of Sterile Product Manufacturing Support, Baxter Healthcare Corporation

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…

Antibody
Antibody
article

Next generation antibody therapeutics: Antibody fragments, dual-targeting strategies, and beyond…

9 October 2009 | By Dr Martin Scott, Molecular Cell Biologist, Biopharm R&D, GlaxoSmithKline and Dr Neil Clarke, Molecular Cell Biologist and Biology Section Leader, Biopharm R&D, GlaxoSmithKline

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…

article

Raman spectroscopy in pharmaceutical analysis

9 October 2009 | By

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…

article

Sleep changes as translational pharmacodynamic biomarkers

9 October 2009 | By

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.…

article

Article 5: qPCR data analysis – Amplification plots, Cq and normalisation

9 October 2009 | By

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…

Big Data
Big Data
article

Real-time NIR monitoring of pharmaceutical blending processes with multivariate quantitative models

9 October 2009 | By Dr. Nicolas Abatzoglou, Professor and Chairman of the Department of Chemical & Biotechnological Engineering of the Université de Sherbrooke; Pierre-Philippe Lapointe-Garant, PAT Scientist and Jean-Sébastien Simard, Technical Services, both Wyeth Pharmaceuticals

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…

article

MipTec 2009 – The Leading European Event for Drug Discovery

9 October 2009 | By

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…