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19 February 2014 | By Cindy Novak-DeLaurell, Systems Application Consultant, Allergan
Over the past 20 years, I have participated in numerous LIMS implementation projects in a variety of roles. I have participated as a subject matter expert (SME), validation coordinator, programmer, System Administrator and technical representative, and have worked both in the laboratories and IS during these projects; gaining an insight…
The mammalian target of rapamycin (mTOR) has emerged as a promising cancer therapeutic target. Some rapamycin analogues (rapalogues) as mTOR allosteric inhibitors are FDA-approved drugs for treatment of certain types of cancers. However, the modest clinical anticancer activity of rapalogues, which preferentially inhibit mTOR complex 1, in most types of…
19 February 2014 | By Juha K. Rantala, Department of Biomedical Engineering and Knight Cancer Institute, Oregon Health and Science University
The last 10 years in biomedical research marks the period of deepening our understanding of the human genome. In the context of cancer research, The Cancer Genome Atlas (TCGA) and related international genomics efforts have now revealed the full complexity of genomic aberrations in human cancers that are postulated to…
Any pharmaceutical product, whether manufactured in the hospital or industrial environment, has the potential to be contaminated with microorganisms. With sterile products, any microbial contamination presents an unacceptable risk; with non-sterile products, the implication of the contamination is dependent upon whether the microorganism can be considered ‘objectionable’, and then to…
In Issue #6 2013: PAT in-depth focus, Lab Automation, Proteomics, Next Gen Sequencing, Screening in-depth focus, Microbiology...
In this Screening In-Depth Focus: Technological and sociological advances in HTS: evolution and revolution?; Flow cytometry as a drug screening platform; Show Preview: High-Content Analysis 2014
In this Process Analytical Technology (PAT) In-Depth Focus: Presenting a rational approach to QbD-based pharmaceutical development: A roller compaction case study, PAT for pharmaceutical spray drying, PAT Roundtable, Show Preview: IFPAC® 2014...
Specifications (test and acceptance criteria) for active pharmaceutical ingredients (APIs) and drug products are defined in ICH Q6A. It ‘establishes a set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use.’ The guidance is sub-divided into universal tests applicable…
15 December 2013 | By Sergio C. Chai, Asli N. Goktug and Taosheng Chen, High Throughput Screening Center, Department of Chemical Biology and Therapeutics, St. Jude Children’s Research Hospital
Liquid handlers are ubiquitous and essential tools in every aspect of the drug discovery arena. Innovations in the past few decades resulted in a sizeable array of devices. With so many choices, it is important to identify appropriate instrumentation for a particular screening strategy, which should be based on unique…
15 December 2013 | By Joerg Reinders, Institute of Functional Genomics, University of Regensburg
Proteomics has evolved during the last few years from a time-intensive, cost-intensive and hard-to-reproduce technique in basic research to a versatile and reliable tool in various areas of pharmaceutical research. The exploding progress in mass-spectrometry-compatible protein and peptide-separation methods led to the development of new approaches particularly suited for monitoring…
Preclinical cancer models allow us to gain insight into therapeutic potential and mechanism of anti-cancer agents early in the drug discovery process. Whilst traditional array-based approaches have made a significant contribution to the characterisation of these models, the advent of next generation sequencing has revolutionised genomic research and is anticipated…
Invasive fungal infections associated with high mortality rates are common in hospital settings, especially in intensive care units where patients may be immune-compromised, subject to invasive procedures and treated aggressively with antibiotics. The most common nosocomial fungal infections in descending order are due to the genera Candida, Aspergillus, Rhizopus, Fusarium…
15 December 2013 | By Christos Georgakis, Department of Chemical and Biological Engineering and Systems Research Institute for Chemical and Biological Processes, Tufts University and Gregory M. Troup, Merck Research Laboratories, Merck & Co., Inc
Process Systems Engineering (PSE) has had a profound impact in the chemical, petroleum and petrochemical industry in the last 30 - 40 years. Even though PSE has already started to make a significant impact on the pharmaceutical industry, there are substantial additional benefits that can be derived. The purpose of…
15 December 2013 | By Klarke M. Sample and Roy Bicknell, University of Birmingham
It is possible to attack the vasculature within solid tumours and achieve an anti-cancer effect. In the last decade, a number of studies have utilised cDNA libraries, SAGE analysis and microarrays to identify potential drug targets in the tumour endothelium. Modern sequencing technologies are likely to be a far more…
18 November 2013 | By Dr Kevin Robinson
The response to a lack of skilled managers is often to take a ‘sticking plaster’ approach to the problem by deciding to take on one or two pricing managers and have them report into the commercial or finance team. Experience to date shows that this will have limited success, for…
