Authors
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Scale up of Fed-Batch Culture to Produce Plasmid DNA in Escherichia coli (Peer Reviewed)The authors present scale-up from a 5-L fermentor to a 50-L pilot-scale using the criterion of constant power consumption per unit liquid volume.
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Manufacturing Process Development for an Epidermal Growth Factor-Based Cancer VaccineThe Center for Molecular Immunology (Havana, Cuba) has been working on a novel cancer immunotherapy targeting the epidermal growth factor (EGF). The vaccine is composed of a chemical conjugate of EGF and a carrier protein (rP64k), designed to trigger an anti-EGF antibody response. The results of studies of molecular characterization, immunogenic activity, and clinical data are presented here.
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The Development and Application of a Monoclonal Antibody Purification PlatformA purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.
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India's Clinical Trials Market AcceleratesMost local and global clinical research organizations (CROs) consider an operational presence in India as key to their overall business plans. India is clearly on course to become the next hub for clinical trials.
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Advances in Single-Shot Vaccine DevelopmentThe disadvantages of the traditional vaccine regime (prime plus boost) have spurred the development of single-shot vaccines. This article describes the development and manufacture of a prototype single-shot vaccine that uses microspheres made from cross-linked modified dextran polymers for controlled release of the antigen.
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Disposables for Bioprocessing: Making the TransitionTransitioning from stainless steel technology to disposable technology in bioprocessing.
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Maximizing Yields of Plasmid DNA ProcessesRecombinant protein and plasmid DNA production using microbial expression systems is the cornerstone of many biologics manufacturing processes. HCD methods are commonly used for these processes because of the advantages they provide.
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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
