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7 April 2008 | By
Recent years have seen great upward leaps in the development of mass spectrometry applied to the field of proteomics. Today it is possible to take a complex biological sample such as organelles, cells, tissue or a biofluid, perturbed or stimulated in some way, and identify and quantitate up to several…
7 April 2008 | By
The increasing need for improved efficiency, precision and 24/7 operation imply more and more sophisticated measures in laboratory automation. This is true for a variety of fields – from pharmaceutical to food, agricultural, and the petrochemical industry, as well as forensics and medical diagnostics. Chemical and biological tests have to…
7 April 2008 | By
Since the FDA revolutionary white papers[1,2] in 2004, the industry has talked non-stop about the potential of PAT (Process Analytical Technology) and more recently, QbD (Quality by Design). These topics have found regular spots in conferences, press and internal company discussions. It has been widely stated3 that the benefits are…
7 April 2008 | By
The pharmaceutical industry has, for many years, operated in a special environment with strong regulation and patent protection. Production efficiency and yields have not, as in many other industries, been the major competition parameter and, as a result of this, pharmaceutical manufacturing has a low manufacturing performance compared to other…
7 April 2008 | By
Pharmaceutical analysis in drug development mainly focuses on methods to identify and quantify potential new drug candidates, determine purity, identify by – products and degradation products in compatibility and stability studies, and to determine the drug substance’s fate in the organism. Challenging tasks like these require sophisticated techniques, dedicated equipment…
7 April 2008 | By
It is clear that pharmaceutical analysis plays a very important supporting role in drug development. Already during the conception of a candidate drug, for example by chemical synthesis, suitable analytical means are required to determine the identity and purity of the compound. Subsequent studies performed on candidate drugs with the…
7 April 2008 | By
Contract Research Organisations (CROs) provide independent development services for pharma, biotechnology, and medical device markets. Services offered by CROs have evolved from providing basic support, to a wide range of services catering to various needs of the market and the sponsors. The United States is the world’s largest market for…
7 April 2008 | By
Research within the pharmaceutical industry has tripled in the past 25 years, with the pipelines of the top companies doubling. Stricter regulations, guidelines, price and reimbursement legislation all result in a changing business environment. The growing market in drug development and increase in research and development (R&D) investment, including that…
7 April 2008 | By
In the highly competitive contract manufacturing outsourcing (CMO) market the industry is on the rise with pharmaceutical and biotechnology companies targeting their resources towards marketing, rather than production and drug discovery. Pharmaceutical and biopharmaceutical companies are faced with the need to outsource the manufacture of their products for a variety…
19 March 2008 | By
The early 21st century has seen a revolution in RNA biology, bringing with it the prospect of a new class of medicines based on RNA. What are the prospects for developing these RNA-based medicines for the growing medical problem of neurodegenerative disease and what are the challenges to making these…
19 March 2008 | By
Most people in molecular biology today are not old enough to remember pre-PCR. But try to do your job without it and you will see what a difference that simple little technique has made. ‘Polymerase Chain Reaction’ is now a word in Merriam Webster’s Collegiate Dictionary and if you put…
19 March 2008 | By
Type 1 diabetes is an autoimmune disease, characterised by immune infiltration into the islets of Langerhans, resulting in the destruction of insulin producing b-cells. Over recent years, evidence has been collected on the important role of chemokines in the recruitment of immune cells leading to the pathology of this disease.…
19 March 2008 | By
The complexity of drug discovery faces many challenges; principally, the failure of drug candidates during the development process as a result of adverse effects or lack of efficacy. A key reason for this high attrition rate is that we are only just beginning to understand the complexity of the response(s)…
19 March 2008 | By
The impact of biomarker technology and biomarker strategies in pharmaceutical development is still in its infancy; but the impact is already proving significant. Biomarker strategy forms the basis for personalised medicine, the industry/regulatory focus centres on improving the success rate and reducing the high attrition rate often encountered in early…
19 March 2008 | By
High content screening (HCS) is based on subcellular imaging using automated microscopy, in combination with automated image analysis. High content screening was first introduced over a decade ago as one of the promising new technologies, intended to address the bottleneck of secondary assays in the development of new drugs. Since…
