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Implementing QbD Initiatives: But what is Quality? How do you measure Quality? Is Quality related to a product, a process or a system or all above? The Quality Transformation is a culture of commitment to continual improvement read more
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Biopharma Suppliers’ Budgets Increase: Bellwether for Better Times: Biopharmaceutical companies have weathered a rough recession, layoffs, and budget trimmings. These cutbacks have affected their vendors as well. In BioPlan Associates’ 8th Annual Report and Survey of Biopharmaceutical Manufacturing, we surveyed 352 biotherapeutic manufacturers, and 180 of their vendors, in 32 countries. The substantial budget cuts at vendors that started in 2008 have begun to turn around. We measured 10 budget areas for vendors to this industry. Sales budgets, the only area that did not take a downturn, continued to increase, this year, by an average of 5% globally. read more
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Single Use Device Adoption Impacted by Slow Standards Setting: Leachables and extractables category, (which also leads the 2011 list of Factors Restricting Use of Disposables) are a key concern. Worries over “leachables and extractables” have increased for both groups over the past 4 years. read more
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Higher Tech Outsourcing Repositions CMOs: While many biomanufacturers continue to view outsourcing as part of their cost reduction approach, more are considering how they can incorporate outsourcing of the technical more complex upstream and downstream operations as part of their business strategy. If biopharma companies hold to these plans, the outsourcing arena may change considerably over the next few years. read more
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Single Use Bioreactors Lead in New Use and Market Penetration: Single use technologies are strong change agents in biopharma manufacturing. Disposable devices emerge once again as a top new technology of interest among the 352 surveyed biomanufacturers in BioPlan Associates, Inc.’s 2011 8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production. read more
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The Outsourcing Market – A Plethora of Choices: Globalisation’s growth and prevalence of the pharmaceutical market, calls for proactive approaches to manage its risks, namely the size and complexity of value chains and the increased labor market competition. = read more
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A Revolutionary Paradigm Shift in Big Pharma's Organisational Development: A paradigm is the conceptual framework upon which we build our world; it is built upon past experiences; if we are not willing to make shifts in our paradigms, we will remain stagnate in our growth; a paradigm shift is a change from one way of thinking to another; it is something that does not happen like self generation it is driven by change. read more
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Taxing “Globesity” To Save Our Children: Will “Fat taxes” affect consumption, and eventually obesity? The impact of imposing taxes on the consumption of certain foods depends on the responsiveness of consumers to price changes, i.e. price elasticity. It is difficult to predict how consumers will react to price changes caused by taxation. read more
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Big Pharma Cannot Afford to be Lost in Translation: Since more and more clinical research and drug manufacturing are being done in multiple countries and in multiple languages, quality language services can help bring a drug to market faster, and can help streamline the clinical trial process. Translation may be required at many stages, including clinical research, regulatory submission and review, production and marketing. read more
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Implementing Single Use Systems: The deployment of Single Use Systems (SUS) has become a hot topic within the biopharmaceutical industry. From its origins in filtration technology and blood containers, the technology has developed rapidly. In the last couple of years and in response to end-user demand, all of the major suppliers have improved their capabilities and technology offering and it’s now possible to exploit single-use technology for practically all upstream and downstream bioprocess and fill and finish operations. read more
Events of Interest
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Global Pharmaceutical Distribution 2012
Venue to be Confirmed, Amsterdam, The Netherlands
September 18- 19, 2012 -
Cool Chain Logistics 2013
Congress Center Basel, Basel, Switzerland
January 28- 30, 2013 -
Information Governance & eDiscovery for Pharma, Biotech and Medical Devices
London, UK
June 26- 28, 2012 -
Cold Chain Global Forum 2012
Chicago, IL
September 24- 28, 2012
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