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Pharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
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Articles
Implementing chemometrics in late stage development and manufacturing
26 April 2012 | By Geir Rune Flåten, former Chemometrician Leader in Global Manufacturing and Supply at GlaxoSmithKline
Chemometrics was defined as a research area in 1974 and developed rapidly through the following decades in parallel with the fast paced improvement in analytical technologies and computational power for lab instruments and sensors. Chemometrics is essentially the translation of measured signals characterising a sample or a process into meaningful…
Building robust PCR/qPCR assays
26 April 2012 | By Linda Starr-Spires, Director, Nucleic Acid Methods Platform, Global Clinical Immunology Department, Sanofi Pasteur
The process of building robust PCR/qPCR assays is a matter of perseverance and consistency. A few questions that should be answered prior to starting development will help make the process more efficient and effective: Does the assay need to simply detect the presence of the target (qualitative), or must it…
Applications of Raman, CARS and SRS imaging in dosage form development
26 April 2012 | By Clare Strachan, Senior Lecturer Pharmaceutical Sciences, School of Pharmacy, University of Otago
The use of Raman spectroscopy in pharmaceuticals has grown enormously since its appearance on the scene in the 1980s1-4. While typical Raman spectroscopy setups are able to provide chemical and physicochemical information about the sample on the bulk level, most solid samples in the pharmaceutical setting may not be assumed…
Discovery chemistry outsourcing
26 April 2012 | By Luigi La Vecchia, Director of the Preparations Laboratories, Novartis Institute for Biomedical Research
In 2002, Novartis decided to create a new research centre in Cambridge, MA. This was accompanied by a significant increase in headcount in medicinal chemistry. Within two years, this resulted in a strongly increased demand for prep-scale synthesis which in turn led to priority issues and to prolonged turnaround times…
Outsourcing in early drug discovery: Evolution and opportunities
26 April 2012 | By Jayshree Mistry, Paul Lloyd, Kevin Oliver and Peter North, GlaxoSmithKline R&D and Duncan Judd, Awridian
This article describes the evolution of outsourcing within early drug discovery at GlaxoSmithKline (GSK), specifically for chemistry services applied to developing a compound from the screening hit through lead optimisation. It will touch on different business models, factors to consider when selecting potential CROs, the benefits of outsourcing and CRO…
GPCR screening and drug discovery: Challenges and latest trends
26 April 2012 | By Sofia M.A. Martins, João R.C. Trabuco, Gabriel A. Monteiro and Duarte Miguel Prazeres, Institute for Biotechnology and Bioengineering, Instituto Superior Técnico, Technical University of Lisbon
G-protein coupled receptors (GPCRs) are one of the most popular drug targets today. Almost one third of the approved drugs currently available rely on some kind of interaction with these receptors. The annual revenues are around USD 30 billion (109) and the fact that one quarter of the top US…
Rapid micro methods and EMA’s post approval change management protocol
26 April 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the second paper in our continuing series on Rapid Microbiological Methods that will appear in European Pharmaceutical Review during 2012. In my last article, we discussed a number of myths or misconceptions associated with the validation and implementation of rapid microbiological methods (RMMs). In fact, most RMM myths…
Under the microscope: Aric Meares, CEO, Azbil BioVigilant
26 April 2012 | By Helen Difford, Editor
Want to avoid a devastating drug shortage? Aric Meares, CEO of Azbil BioVigilant, says rapid microbial detection technology is a critical part of the solution...
Mass Spectrometry In-Depth Focus 2012
In this free to view Mass Spectrometry In-Depth Focus: Mass spectrometry in drug discovery - Proteomics, small molecules and metablomics; Quantification of membrane drug transporters and application in drug discovery and development; Mass spectrometry leaders roundtable...
New year, old challenges!
28 February 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the first of many articles in our continuing series on Rapid Microbiological Methods that will appear in European Pharmaceutical Review during 2012. For the past two years, I have enjoyed sharing with you a broad range of topics associated with the validation and implementation of rapid microbiological methods…
Working independently or as part of a team: Which works best?
When I sat down to write this article, my immediate thought was about work styles. Is it better to work independently or in teams? Wouldn’t it be great to hear from someone on the ‘floor’ who has worked both in the lab and in the production environment? Work styles: independent…
Targeted therapy in metastatic melanoma
28 February 2012 | By Janina Staub and Jochen Utikal, Department of Dermatology, Venereology and Allergology, University Medical Center Mannheim, University of Heidelberg & Skin Cancer Unit, German Cancer Research Center
During the last few years, significant improvements in the treatment of metastatic melanoma were reported, targeting molecules involved in the pathogenesis of melanoma. Different clinical trials were able to prove a prolonged overall survival by introducing new therapeutic agents. Hereby an imunomodulating therapy with the anti-CTLA-4 antibody ipilimumab has been…
MRI in drug discovery
28 February 2012 | By Peter R. Allegrini, Novartis Institutes for BioMedical Research
MRI is widely used for clinical diagnosis as well as in research areas such as preclinical drug discovery, clinical development and also in therapy monitoring. MRI allows non-invasive acquisition of tomographic images of soft tissue with high resolution and contrast. Furthermore, its ability to assess organ function in a broad…
Conformational Bias: A key concept for protein kinase inhibition
28 February 2012 | By Henrik Möbitz, Global Discovery Chemistry, Computer Aided Drug Design, Novartis Institutes for Biomedical Research and Doriano Fabbro, Expertise Platform Kinases, Novartis Institutes for Biomedical Research
Protein kinases act as molecular switches with remarkable plasticity and dynamics upon interaction with specific regulatory domains as well as modulators. Conformation provides a conceptual framework for understanding many aspects of kinase biology. The kinase domain has precise structural prerequisites for signal transfer and can oscillate between two major conformations:…
Recent developments in the use of LCMS in process pharmaceutical chemistry
28 February 2012 | By Dr. Florence O. McCarthy, Department of Chemistry, Analytical and Biological Chemistry Research Facility, University College Cork
Liquid Chromatography Mass Spectrometry (LCMS) is a powerful technique that has recently undergone exponential growth in its application to pharmaceutical synthesis. This perspective will outline the general principles of LCMS, detail some recent approaches and the benefits to be derived from its use at an early stage of process development.…
