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Advances in Animal-Free Manufacturing of BiopharmaceuticalsIn addition to existing guidance, in January 2007 the FDA announced further proposals to prohibit the use of certain bovine materials as ingredients in some medical products or as elements of product manufacturing.
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Technology Licensing — From First Steps to Executing a PlanCarefully prosecuted patent applications lead to patents with valid and enforceable claims that provide broad coverage for your technology.
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A Study of Leachables for Biopharmaceutical Formulations Stored in Rubber-Stoppered Glass VialsA systematic approach facilitates formulation component selection.
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Recombinant Vaccine Production in YeastHuman HBV can be grouped into eight genotypes, which differ by at least 8%.
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The Grand AlliancesThe life sciences industry continues to move at an astonishing pace. Covering biotechnology, healthcare, pharmaceuticals, informatics, tools, instrumentation, and device companies, the sector draws from a vast, multidisciplinary array of technologies including optical, software, engineering, electronics, and nanotechnology.
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Recombinant Vaccine Production in YeastHuman HBV can be grouped into eight genotypes, which differ by at least 8%.
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Technology Transfer: How to Make It a Competitive AdvantageIf a company wants to reduce costs, it should consider outsourcing some manufacturing and analytical testing to low-cost sites.
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Patents: Patent Strategies for Biotechnology EnterprisesCompanies in the biotech industry typically require one or several partners as they complete the product development cycle.
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The Company at the Crossroads. Part 2: Build or Buy?When making critical decisions such as whether to build or buy critical capabilities, companies need a decision-making approach that weighs risks and rewards as a science with adequate inputs, repeatable processes, and measurable results. The method must also accommodate the human factor by encouraging wide participation and providing the kind of neutral decision criteria that satisfies participants about the objectivity of the process.
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New-Age Vaccine Adjuvants: Friend or Foe?Adjuvant-caused vaccine reactions are one of the most important barriers to better acceptance of routine prophylactic vaccination.
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Vaccine Characterization Using Advanced TechnologyWith the advent of high-resolution mass spectrometers and highly sensitive MS instruments, vaccine characterization has entered a new phase.
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Gastric-State-Controlled Bioequivalence StudiesEstablishing bioequivalence is difficult for drugs with high inter-subject variability or strong dependence on the physiological state of the gut.
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Quality by Design in the CMO EnvironmentHow the authors used design of experiments and quality by design principles to develop a hydrophobic interaction chromatography step.
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The Adjuvant Patch: A Universal Dose Sparing Approach for Pandemic and Conventional VaccinesIn animal studies, we have demonstrated that the dose of an injected H5N1 vaccine candidate can be significantly reduced by using a skin patch containing E. coli heat-labile enterotoxin (LT) applied over the injection site. LT-activated epidermal Langerhans cells migrate to the nearby draining lymph node and enhance the immune response to the injected antigen. A dry patch formulation has been optimized as a dose sparing strategy for pandemic flu and other vaccines. Iomai Corporation has developed a proprietary stabilizing formulation for the patch that allows use and storage at ambient temperature. The patch withstands temperature extremes during shipment, and is suitable for stockpiling.
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Final Word: PEGylation — A "Sunset" Technology?Recent advances and new applications suggest a favorable future for PEGylation technology.
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Recombinant Vaccine Production in YeastHuman HBV can be grouped into eight genotypes, which differ by at least 8%.
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The Changing Landscape of Global Vaccine Development and Market PotentialIt is hoped that HIV patients' own immune responses can be strengthened by vaccines so they will not have to rely exclusively on antiretroviral drugs.
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Rapid High-Throughput Feed OptimizationGrowth of CHO cell cultures in a shaker plate model system was demonstrated to be comparable to growth in shake flasks.
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Final Word: Are Biotechnology Meetings and Symposia Doing the Job?Sir Isaac Newton said, back in 1676, "If I have seen further, it is by standing on the shoulders of Giants." Newton's modest self-assessment of his scientific competence holds relevance in today's debate on the value of scientific meetings, and our quest for faster scientific discovery.
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The Adjuvant Patch: A Universal Dose Sparing Approach for Pandemic and Conventional VaccinesIn animal studies, we have demonstrated that the dose of an injected H5N1 vaccine candidate can be significantly reduced by using a skin patch containing E. coli heat-labile enterotoxin (LT) applied over the injection site. LT-activated epidermal Langerhans cells migrate to the nearby draining lymph node and enhance the immune response to the injected antigen. A dry patch formulation has been optimized as a dose sparing strategy for pandemic flu and other vaccines. Iomai Corporation has developed a proprietary stabilizing formulation for the patch that allows use and storage at ambient temperature. The patch withstands temperature extremes during shipment, and is suitable for stockpiling.
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Optimized Vaccine Development and Manufacturing: A Technology OverviewThe replacement of a IgG ELISA assay with an SPR-based test can shorten the production workflow by one day.
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Back to the FutureOne company even connected hollow fiber cell culture chambers to living cows.
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Supplementary Material for Allogeneic Versus Autologous Stem-Cell Therapy: Manufacturing Costs and Commercialization StrategiesThis article contains online-exclusive supplemental material for Malik's article entitled, "Allogenic Versus Autologous Stem-Cell Therapy."
