Authors
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The Challenges and Benefits of Disposable TechnologiesInterview with David Radspinner, director of global marketing & customer applications, bioprocess production at Thermo Fisher Scientific.
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Chromatography Optimization StrategyRobust packing procedures can improve process performance and increase resin lifetime.
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Elements of Quality by Design in Development and Scale-Up of Freeze-Dried ParenteralsDesign space concepts are key to a successful technology transfer.
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Single-Use Technologies—A Contract Biomanufacturer's PerspectiveOne of the challenges of adopting single-use technology is that not all cell lines are compatible with disposable bioreactors.
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Antibody Purification with an Integrated Disposable AssemblyComparison of the integrated assembly purified MGG to the control revealed that the purity if the MGG was very high.
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Regulatory Issues with New and Unlicensed Veterinary Biological ProductsThere are six mechanisms for bringing a veterinary biologic into use when circumstances demand a rapid response and full licensure will take too long.
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Antibody Purification with an Integrated Disposable AssemblyComparison of the integrated assembly purified MGG to the control revealed that the purity if the MGG was very high.
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Outsourcing: Transition from Business Process Outsourcing to Knowledge Process OutsourcingBy outsourcing high-end processes that demand advanced analytical and technical skills, biopharm companies are reaping substantial savings.
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Integrating Single-Use Connection Components into Filter Integrity Testing Reduces Manufacturing RiskSingle-use connections can help drug manufacturers maximize efficiency in every step of the manufacturing process.
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Providing Process Development, Flexible Manufacturing, and Analytical Services to the Global Biotech CommunityCook Pharmica LLC is a biopharmaceutical contract manufacturer of mammalian cell-culture products. Cook Pharmica's mission is to provide process development, flexible manufacturing, and analytical services to the global biotech community, enabling its partners to bring their life-saving discoveries to patients. Founded in 2004, Cook Pharmica is a privately held, wholly-owned subsidiary of Cook Incorporated.
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Japan: Discover Asia's Largest and the World's Second Largest Biotechnology MarketBiopharmaceuticals currently account for 34% of Japan's $12 billion biotech market. Technology partnerships and increased R&D are the keys to further growth.
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Disposable Process for cGMP Manufacture of Plasmid DNADisposables are increasingly being used in the manufacture of biopharmaceuticals. This article describes the design of a fully disposable process for the cGMP manufacture of clinical trial grade plasmid DNA. It addresses the rationale for implementing such a process with respect to the manufacture of patient-specific plasmid DNA vaccines for the treatment of leukemia. The process incorporates a number of disposable technologies, which are simple to use and thus reduce the need for investment in expensive equipment and cleaning validation.
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Outsourcing Virtually Everything: Making the Semi-Virtual Model WorkPartnering with a surging number of CROs, CMOs, CSOs, and other niche providers, biopharm companies in 2007 will have an estimated spend of more than $7 billion on international clinical trial outsourcing alone.
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IP Briefs: The Shifting Landscape of Patent LicensingIn light of these recent decisions, patent holders must devise new strategies for patent enforcement and licensing.
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IP Briefs: Demystifying the Patent Reform Act and its Impact on Company IP StrategyThe Act will establish third party rights to challenge the validity of a patent through postgrant opposition proceedings.
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How to Develop a Pool of Talented PeopleCMOs must take a proactive approach to ensure the availability of local talent
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Antibody Purification with an Integrated Disposable AssemblyComparison of the integrated assembly purified MGG to the control revealed that the purity if the MGG was very high.
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HIV Drugs Produced from Goats Show PromiseMolecular mimicry is a common, but undesirable, property of disease proteins. Sequence similarities between cancer proteins and self-proteins allow tumor cells to hide, thereby avoiding attack from the immune system. HIV uses the same evasive tactic.
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Regulatory Issues with New and Unlicensed Veterinary Biological ProductsThere are six mechanisms for bringing a veterinary biologic into use when circumstances demand a rapid response and full licensure will take too long.
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Rapid Development and Optimization of Cell Culture MediaChinese hamster ovary (CHO) cells are used extensively in the biopharmaceutical industry to produce recombinant proteins that require post-translation modification for full biological functionality. Optimization of culture conditions for recombinant CHO cell lines presents challenges in light of the diverse nutritional requirements observed with different clonally derived cell lines.
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Platform Technology for Developing Purification ProcessesThe future of therapeutic MAbs lies in the development of economically feasible downstream processes.
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The Global Biomanufacturing Outsourcing MarketThe fast growth of the global biopharmaceutical market has prompted global pharmaceutical and biotechnology companies to increase their R&D investment in biologics.
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Increasing Efficiency and Throughput with Separation and PurificationIncreasing efficiency and throughput in downstream separation and purification performance is currently a major focus in the biopharmaceutical industry. Traditional TFF systems cannot be scaled in a linear fashion to meet the projected demand for fermentation and cell culture based products. NCSRT has created a patented line of filtration solutions that address the bottlenecks currently experienced as biopharmaceutical products scale up from clinical trials to blockbuster production quantities.
