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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
UV-Vis scan-based quality control of assay-ready plates for improved data integrity
19 April 2011 | By Gary K Smith, M Anthony Leesnitzer, Lois L Wright, Iona Popa-Burke, Trevor Casserly, Luke Miller, Melissa Gomez & Iris Scherer, GlaxoSmithKline
Quality biological data requires both a high quality assay and a high quality compound. While assay quality is very closely monitored and has been intensively studied in the past, the quality of the final compound solutions being tested in an assay has received little attention. Quality of these samples is…
Molecular drug targets in autophagy
19 April 2011 | By Robin Ketteler, MRC LMCB, University College London
Autophagy is a cellular stress response to diverse stimuli such as starvation, infection and DNA damage. Autophagy plays important roles in the progression of various diseases including cancer, neurodegenerative diseases and Crohn’s disease. Despite recent advances in our understanding of the autophagy machinery, surprisingly little effort has been undertaken towards…
DiscoveRx Interview
19 April 2011 | By Sailaja Kuchibhatla, Senior Vice President Business Development DiscoveRx Corporation
“The goal of DiscoveRx has always been centred on creating technologies that enable the highest levels of innovation and development to enrich drug discovery,” Sailaja Kuchibhatla, Senior Vice President Business Development, asserts. Founded in 2000, DiscoveRx solved an unmet need within the GPCR industry by commercialising a functional, naturally coupled…
Overview of rapid microbiological methods evaluated, validated and implemented for microbiological quality control
19 April 2011 | By Oliver Gordon, Jennifer C. Gray, Hans-Joachim Anders, Alexandra Staerk & Oliver Schlaefli, Novartis Pharma Stein AG and Gunther Neuhaus, University of Freiburg
The risk for patients through spoiled or otherwise adulterated pharmaceuticals has been acknowledged for many centuries and led to the establishment of Good Manufacturing Practice (GMP) and pharmacopoeial guidelines. Besides chemical purity, pharmaceuticals also have to meet microbiological standards, the latter primarily depending on the administration route. Drug products which…
Article 2: Direct detection of microorganisms using viability-based technologies
19 April 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the second in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2011. In my last article, I provided an overview of growth-based rapid microbiological methods (RMMs). This was a good place to start my review of RMM technologies, as most…
Proteomics and target identification in oncology
16 February 2011 | By Hubert Hondermarck, Professor and head of U908 INSERM research unit – Growth factor signalling in breast cancer – functional proteomics, University of Lille
The recent progresses in the field of proteomics now enable large scale, high throughput, sensitive and quantitative protein analysis. Therefore, applying proteomics in clinical oncology becomes realistic. From the analysis of cell cultures to biological fluids and tumour biopsies, proteomic investigations of cancers are flourishing and new candidate biomarkers and…
Advancing high content analysis towards improving clinical efficacy
16 February 2011 | By Neil Carragher, Edinburgh Cancer Research UK Centre, Institute of Genetics and Molecular Medicine, University of Edinburgh
High-content analysis is primed to play a prominent role in a new era of drug discovery research that places greater emphasis on clinical translation at all stages of the discovery process from target identification to proof-of-concept testing. High content analysis provides a technical bridge between reductionist targetdirected drug discovery approaches…
Pharmaceutical materials science and disorder: The next steps
16 February 2011 | By John Murphy, Senior Scientist, Materials Science, Pfizer
Over the past decade, the pursuit of materials science within the pharmaceutical industry has largely focused on determining the crystal structure of our drug molecules and ensuring that the most stable polymorphic form is carried forward and maintained through development, as the manufacturing issues and regulatory impact arising from the…
Establishing assays and small molecule screening facilities for Drug discovery programs
16 February 2011 | By Sheraz Gul, Vice President & Head of Biology, European ScreeningPort GmbH
Although many of the marketed small molecule drugs have been discovered by research and development efforts within the pharmaceutical industry, there has been a paradigm shift with external sources increasingly being relied upon to fill their pipelines. This trend is likely to increase and the key pre-clinical activities carried out…
Translational science: The future of medicine
16 February 2011 | By Bahija Jallal, Executive Vice President, Research & Development, MedImmune
When the term ‘translational medicine’ first came to prominence at the turn of the century, there were suspicions that this concept was simply a rebranding of conventional medical research, describing the process in which scientific discovery at the laboratory bench eventually translates to an effective therapy at the patient’s bedside.…
Pulmonary inhalation aerosols for targeted antibiotics drug delivery
16 February 2011 | By Chun-Woong Park & Heidi M. Mansour, University of Kentucky, College of Pharmacy and Don Hayes Jr, University of Kentucky, College of Medicine
Targeted pulmonary drug delivery of antibiotics by inhalation aerosols can play significant roles in the treatment of cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD) and in other pulmonary diseases where chronic airway infections exist. Direct administration to the lung as targeted pulmonary inhalation aerosol delivery is uniquely able to…
Article 1 Rapid microbiological methods 2011
16 February 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the first in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2011. Last year, I provided an overview of rapid microbiological methods (RMMs), including validation strategies, regulatory expectations, the technical and quality benefits of RMMs as compared with conventional techniques,…
Next Generation Sequencing: Current realities in cancer biology
16 February 2011 | By Ross Sibson, Director of Research, Applied Cancer Biology Group, University of Liverpool
The rate of progress in molecular cell biological sciences has become dramatic. This is fuelled in part by developments in technology, none more so than in the field of nucleic acid sequencing. So-called Next Generation Sequencing Platforms promise to revolutionise our understanding of the importance of genetic differences on an…
Authentication of medicines using Raman spectroscopy
16 February 2011 | By Sulaf Assi, University of Hertfordshire, and Robert Watt & Tony Moffat, The School of Pharmacy, University of London
Raman spectroscopy offers a rapid and non-destructive technique for the identification of counterfeit medicines. Handheld Raman instruments offer the advantages of carrying the laboratory to the sample and giving a rapid pass or fail answer for the medicine inspected. It can identify a medicine regardless of its physical form as…
Evaluation of cellular response to nicotinic compounds using optical label-free technology
16 February 2011 | By Isabel Coma & Julio J. Martin, Screening and Compound Profiling, GlaxoSmithKline R&D Pharmaceuticals
Cell signalling circuits are likely to have a key role in the future of pharmacological discovery and medical treatment. There is consensus about the importance of understanding cell components and their function, not at the level of genes, but at a higher level of abstraction, involving their pathways and circuits.…
