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Expediting the Technical Transfer of Biopharmaceutical ProductsEstablished, fully validated methodology and SOPs are required prior to initiation of any training activities.
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Specification Setting: Setting Acceptance Criteria from Statistics of the DataThis article shows how Probabilistic Tolerance Intervals of the form, "We are 99% confident that 99% of the measurements will fall within the calculated tolerance limits" can be used to set acceptance limits using production data that are approximately Normally distributed. If the production measurements are concentrations of residual compounds that are present in very low concentrations, it may be appropriate to set acceptance limits by fitting a Poisson or an Exponential Distribution.
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Information Management Systems Enable Manufacturing Facilities to Ramp Up ProductivityPharma industry equipment utilization hovers below 40 percent, which would be an unacceptable figure in most industries.
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Achieving Global Consensus through the International Conference on HarmonizationThe concept of design space has started a minor revolution in our industry.
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The Laboratory Control System: Fulfilling cGMP RequirementsReserve samples of test and control articles must be retained for at least one stability time point after the completion of the study.
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Production of Recombinant Therapeutic Proteins in the Milk of Transgenic AnimalsCapital investments in production plants represent a significant portion of the cost of new recombinant drugs
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Using Volumetric Flow to Scaleup Chromatographic ProcessesExtra column effects must be accounted for to make a valid comparison
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Using Volumetric Flow to Scaleup Chromatographic ProcessesExtra column effects must be accounted for to make a valid comparison
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The CRO Advantage: Outsource Clinical Trials to Launch Biotech Development SuccessLess than 35 percent of all biotech companies have sufficient finances to survive beyond one year.
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Efficient Small-Scale Production of ProteinsOver the last three decades, numerous protein expression systems have been developed with various quality requirements on large and small scales. Huge steps have been made in large-scale protein production in mammalian systems while the small-scale mammalian systems are expensive and inflexible. Thus, small-scale production is done in simpler expression systems, sometimes sacrificing the quality of the proteins. However, relief is on the way.
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Chloroplasts: Transforming Biopharmaceutical ManufacturingA 20% TSP-producing cultivar can generate up to 265 pounds of crude recombinant protein per acre.
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Final Word: New Jersey: Biotech's Ideal Lab LocationAs the fourth largest center for biotechnology and life sciences in the US, New Jersey is home to 15 of the world's 20 largest pharmaceutical companies. More than half of all new medicines approved in the US are developed by New Jersey companies. New Jersey is an ideal location because it offers close proximity to the financial markets in New York and Philadelphia, and a highly skilled workforce, strong funding, government support, and academic expertise.
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Leveraging Asset Performance Management in Pharmaceutical ManufacturingWeb-based asset performance management provides pharmaceutical manufacturing with a number of advantages over traditional asset maintenance and tracking.
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Small-scale Biomanufacturing Benefits from Disposable BioreactorsThe cell density achieved in a CELLine bioreactor is typically 1 to 2 orders of magnitude higher than in a conventional culture vessel
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Maximizing Protein Expression in Filamentous FungiOne of the major challenges in fungal biotechnology is preventing proteases of the fungi from degrading recombinant proteins.
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Spotlight on 4th Generation Electronic Document Management (EDM) Systems...each day a product is delayed is estimated to cost upwards of $1 million to $100 million.
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Downstream Processing: A Revalidation Study of Viral Clearance in the Purification of Monoclonal Antibody CB.Hep-1The HSV-1 and HVP-2 titers were determined by the inoculation of test solutions into Vero cell cultures and calculated using the Reed M?ench method.
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Barriers and Solutions to Effective External Collaboration in BiopharmaAs biopharma companies rapidly change their focus, they may lack the laboratory space, instrumentation, and the scientific knowledge to support biologics research.
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What's Next in Antibody Therapy ResearchThe moral to the story is that the human body is immensely more complex than any computer that we've been able to dream up.
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The United Kingdom: Leading the Global Competition for BiotechAs a company that performs site selection for biopharmaceutical companies worldwide, Fluor Global Location Strategies has witnessed one country truly distinguishing itself from the competition as a worldwide leader in the industry: the United Kingdom. The global competition for biotech investments has been at a fever pitch over the past few years, with varied results.
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Final Word: NIH-Biopharm Interactions and the New NIH Conflict-of-Interest Regulations. . . These new stringent rules will strongly impact the pipeline of scientific talent the NIH has provided the biopharm industry.
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Expediting the Technical Transfer of Biopharmaceutical ProductsEstablished, fully validated methodology and SOPs are required prior to initiation of any training activities.
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Final Word: Creative Solutions Can Ensure Pandemic Flu PreparednessCertain areas of the vaccine market appear to be in vogue again, revitalized by blockbusters such as Prevnar, the pneumococcal pneumonia vaccine that reaped $1.5 billion in sales last year, and the human papilloma virus vaccines, which are projected to reach $4 billion per year.
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Biowaste Management During Biopharmaceutical Plant Start-Up: From Regulatory Guidance to Verified Inactivation MethodsUntil now, there was little data on chemical inactivation of CHO cells and other GMM.
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Production of Recombinant Therapeutic Proteins in the Milk of Transgenic AnimalsCapital investments in production plants represent a significant portion of the cost of new recombinant drugs
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From Smart Tags to Brilliant Tags: Advances in Drug Stability Monitoring"Smart" tags speak only when spoken to. "Brilliant" tags are capable of independent decision-making.
