New drug discovery drives European demand for cell-based assaysA news update from the worldwide lifesciences communications experts at BCM Driven by demands from pharmaceutical, biotechnology and drug discovery companies, cell-based assays are becoming the preferred choice of screening in Europe. As well as offering more accurate representations of real-life models than traditional enzyme- or antibody-based assays, they also offer the possibility of dynamic experimentation by monitoring the numbers or behaviour of live cells. Such insights could lead to more efficient discovery of effective drugs, saving time, money and the need for secondary screening. "Large multinational companies are seeking to perform screens in cell-based systems because they ensure precise whole cell data representative of the physiological condition," says Dr Amarpreet Dhiman, Research Analyst from international growth consultancy Frost & Sullivan ( http://biotech.frost.com). "Cell-based assays are expected to expand in use, especially in lead evaluation and optimisation and pre-clinical evaluation." As a result, assay manufacturers are focusing on developing easy-to-use and highly sensitive assays that provide a continuous record of cellular activity. Already this year, Cybio has launched a new flash luminescence reader for functional screening of the G-protein coupled receptors and calcium channels important in drug discovery and research. Based on the company’s existing technology for 1536-well flash luminescence detection, throughput is now boosted by the introduction of the CyBi-Lumax flash HT. Ultra high throughput is achieved by the use of a CCD camera capable of detecting the well signals from the bottom of a plate. A 16-fold parallel non-contact dispenser injects cells or reagents. The reader’s 16-channel dispenser enables flash luminescence reading times of less than 60 seconds for 384-well plates and less than three minutes in the 1536-well format. Meanwhile the new range of lab-on-a-slide microslides (µ-Slides) from German supplier ibidi allow both cell culturing and high-resolution microscopy to be performed on the same slide and are ideal for cell-based assay procedures in research and high throughput applications. According to ibidi, its technology is completely novel as there are no other perfusion devices designed as disposables currently on the market. While other systems have to be assembled before use, ibidi has stolen a march on the competition with a solution that is both pre-assembled and single packed, ready for use. Another new entrant to the market in 2005 is a nuclear translocation application from Vitra Bioscience. The application tracks the movement of certain proteins from the cytoplasm to the nucleus. These proteins, which undergo the process of translocation, are well-recognised targets for the development of anti-inflammatory drugs. Vitra’s new offering does away with the subcellular segmentation required by conventional analysis. It is developments such as these that Frost & Sullivan expect to increase the Euro 120m market for cell-based assays by over 19% this year. FDA approves first diagnostic chip test for genetic variations A news update from the worldwide lifesciences communications experts at BCM As lab-on-chip technology has moved from concept to reality, it is helping to streamline drug development and reduce drug screening costs. LOCs have already lowered average drug screening costs in the US from US$2 to US$0.0001. This fifty thousand-fold reduction in cost has been driven by improvements in microtechnology and chip manufacture. Now Swiss company Roche has taken the next step with AmpliChip CYP450, which has just won approval from the US Food and Drug Administration for diagnostic use in the USA. AmpliChip CYP450 is the first microarray-based diagnostic test for detection of genetic variations that can influence drug efficacy and adverse drug reactions. The AmpliChip CYP450 test combines the strengths of two industry gold-standards: Roche’s patented polymerase chain reaction ( PCR) amplification technology, which replicates even minute amounts of genetic material to detectable levels, and Affymetrix high-density microarray technology on glass chips no bigger than a thumbnail arrayed with tens of thousands of precisely arranged DNA fragments. The test analyses a patient’s Cytochrome P450 2D6 and 2C19 genotypes from genomic DNA extracted from a blood sample. The results will allow physicians to consider unique genetic information from individual patients when selecting medications and doses of medications for a wide variety of common conditions such as cardiac diseases, pain and cancer. Roche also says that the new test should enable patients to avoid sub-optimal or even harmful treatment choices. This is important, because at the moment it is extremely difficult to know to what extent painkillers and anaesthetics work in different people. Sometimes they do not work at all, whereas slow metabolisers may experience much longer lasting effects of the treatment. Two key genetic regions encoding the enzymes of the cytochrome P450 complex are the CYP2D6 and CYP2C19 genes. The multiple variations in the CYP2D6 gene can result in poor, intermediate, extensive (normal), or ultra-rapid metabolism of CYP2D6-dependent drugs from a variety of classes, including anti-depressants, anti-psychotics, anti-arrhythmics, beta-blockers, pain medications, anti-emetics, and some anti-cancer drugs. Variations in the CYP2C19 gene result in either normal or poor metabolism of CYP2C19-dependent drugs from a variety of classes, including anti-convulsants, proton pump inhibitors, benzodiazepines, and anti-malarials. “The use of this test is an important step forward in making personalised medicine a reality and has the potential to help physicians improve patient outcomes,” added von Prondzynski. It has been estimated that future sales of AmpliChip CYP450 could be worth up to Euro 83 million per year to Roche. At BCM w e focus on the production, coordination and placement of technical and application articles and standard press releases: our expertise ensures your success. Integrating LIMS for future business success A news update from the worldwide lifesciences communications experts at BCM The value of the European market for laboratory information management systems (LIMS) is predicted to grow at nearly 7% per year until the end of the decade. By then it will be worth Euro 300 million. One of the biggest drivers is regulatory compliance, in particular the US Food and Drug Administration (FDA) 21 CFR II regulations mandating electronic documentation. Other factors include globalisation, standardisation of business practices and the need for enterprise-level solutions. However, according to a study carried out by international growth research consultancy Frost & Sullivan (F&S), the long term success of LIMS requires its integration with enterprise resource planning (ERP) systems, chromatography data systems, data archiving and other IT solutions in order to supports users’ business-wide strategies. "LIMS integration with ERP and other information systems permits incorporation of scientific data in business decisions, optimisation of the entire organisation, and better information utilisation among different corporate divisions to ensure smooth and seamless operation of business processes,” noted F&S industry manager Nate Cosper. It’s a point not lost on LIMS suppliers. Already in 2005, GenoLogics Life Sciences has launched ProteumsLIMS Version 2.0. The new version has improved functionality for integrating with analytical software for gels and protein research, as well as new features to improve reporting, usability and workflow support for new experimental techniques. Its ability to seamlessly integrate with leading 2D gel analysis software Progenesis means that labs can pull both experimental and in-depth gel analysis data together with other research information for more sophisticated analysis and decision making. Meanwhile QSI is focusing on the ever-growing contract research market. Labs involved in this sort of work have in the past been reluctant to invest in LIMS systems because of concerns about the time and costs involved with commissioning them. QSI’s out-of-the-box solution includes WinLIMS reporting tools which offer cost effective distributed web reporting. In this way, a laboratory’s customers can simultaneously interrogate the system directly, on line, for their own results. Although the pharmaceutical sector remains the largest end-user for LIMS, both the biotech and petrochemicals industries are beginning to realise its potential. However, different stakeholders have different needs. While management executives emphasise standardisation and organisational control through enterprise integrations, these are often not a high priority for scientists. So LIMS suppliers will have to be flexible in how they market their technology. "Flexible, highly configurable, low maintenance, easy-to-use systems with reduced costs of implementation and ownership are some of the common demands of stakeholder and end-user groups. Vendors that can provide industry-specific functionality with decreased need for source code alterations are likely to capture a larger market share," concluded Cosper. Innovative engineering at heart of Euro 10 billion mAb market A news update from the worldwide lifesciences communications experts at BCM When Georges Köhler and César Milstein first described their hybridoma technique for the generation of monoclonal antibodies (mAbs) in 1975 it was a major breakthrough in molecular biology. The basic idea of fusing tumour cells with antibody producing cells to allow unlimited production of specific antibody molecules is so simple that in 1984 the technique won a Nobel prize. Although the therapeutic and diagnostic implications of mAbs were immediately apparent, it has taken further advances in biotechnology for the technique to realise its clinical potential. Today several hundred mAbs are undergoing clinical trials. A number are already on the market, beginning to fill the vacuum left by ineffective conventional therapies, especially fo r oncology and autoimmune and inflammatory disorders. Genetech’s Herceptin, for example, is aimed at metastatic breast cancer while Abbott Laboratories’ Humira tackles rheumatoid arthritis. Zenapax from Hoffmann La Roche and Simulect from Novartis Pharmacueticals are both used in the prevention of kidney transplant rejection. The popularity of mAbs as therapeutic treatments is growing for two reasons: they are able to target specific antigens within cells tissues and organs, and they minimise side effects. An interesting recent development, however, is the investigation of mAbs for use against more than one disease or even different forms of the same disease. A good example of this is Johnson & Johnson’s Remicade. Originally authorised for treatment of severe and active Crohn’s disease, it was also later approved for reducing the signs and symptoms associated with rheumatoid arthritis. As a result, the European market for mAb therapeutics is now worth Euro 1.05 billion. International growth research consultancy Frost & Sullivan (F&S) has just released a new study in which it predicts that the market will grow at over 34% per year for the next six years. The resulting Euro 10 billion market will be primarily driven by new treatments for oncological conditions and auto immune and inflammatory disorders. In fact the oncology market is estimated to be worth Euro 6 billion by 2011, with auto immune and inflammatory disorders reaching Euro 4 billion. Other areas of interest include cardiovascular disorders, organ transplantation and infectious diseases. As competition intensifies, strategic alliances between mAb developers and big pharmaceuticals companies are accelerating market growth. To capitalise on rising demand, F&S says the pharmaceutical and biotechnology industry will need to continue to evolve towards technology integration and market expansions, even as they work towards offering competitive pricing, developing holistic solutions - from diagnosis to treatment to after care and providing technical and efficient customer care. "Success will depend on a medley of key factors including innovative molecular engineering, shorter development times, higher success rates, robust and efficient intellectual property protection and development of cost-effective manufacturing," concluded F&S industry manager Raju Adhikari At BCM w e focus on the production, coordination and placement of technical and application articles and standard press releases: our expertise ensures your success.
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