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Latest:
An Alternative Platform for Rapid Production of Effective Subunit VaccinesAdjuvant activity can be greatly improved by appropriate formulation of cytosine-phosphorothioate-guanine oligodeoxynucleotides (CpG ODNs).
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Addressing Unmet Medical Needs Through Tailored Vaccine Design: The Importance of Adjuvant SystemsIt is now possible to combine antigens with specific adjuvant systems to create more effective vaccines.
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Meningitis Vaccine Manufacturing: Fermentation Harvest Procedures Affect PurificationCareful analysis of an unusual precipitate identifies defects.
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Quality Management Systems for Small Biopharmaceutical OrganizationsWhat small biotechs need to know about quality management systems.
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Effective Auditing of CMOsIt is important that all stages of the audit be given an equal measure of attention.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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Using NMR Spectroscopy to Obtain the Higher Order Structure of Biopharmaceutical ProductsSimple methods can characterize polysaccharide vaccines and recombinant cytokines at high resolution.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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A Review of Sterile ConnectorsMany factors must be considered when choosing a sterile connector for a given process.
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Manufacturing Vaccines for the Developing WorldA handful of facilities making 200 million single-dose units per year could fast-track the immunization of the developing world.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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Advancing Vaccine Technology to Combat Global Pandemic ThreatsNew technologies such as virus-like particles are promising weapons in the battle against pandemic influenza.
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An Economic Comparison of Three Cell Culture TechniquesComparing the economic feasibility of a typical glycosylated protein.
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An Alternative Platform for Rapid Production of Effective Subunit VaccinesAdjuvant activity can be greatly improved by appropriate formulation of cytosine-phosphorothioate-guanine oligodeoxynucleotides (CpG ODNs).
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Development of a Novel Rolling-Tube Cell Culture Platform and Demonstration of System FeasibilityRolling-tube system balances scale-up accuracy and thoroughput.
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Analytical Tools for Process and Product CharacterizationSelect the best approach to determine critical quality attributes.
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High-Cell-Density Culture to Produce Plasmid DNA for Gene Therapy in E. coliHow to produce Plasmid DNA in a high-cell-density culture.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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Scale-Up and Comparison Studies Evaluating Disposable Bioreactors and ProbesProcess performance was comparable across all scales, and fiber optic sensors appeared interchangeable with conventional probes.
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The Effect of Limiting Phosphate Using the HMS174 Cell LineThe HMS174 strain, in the absence or presence of excess phosphate, can metabolize acetate efficiently.
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The Impact of Cell Culture Medium on Cell Line and Process Development Timelines and StrategiesACF medium sped up cell-line development.
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Release and Stability Testing Programs for a Novel Virus-Like Particle VaccineRelease testing involves both standard potency assays and unique assays (particle size, NA activity) developed to ensure the physical, chemical, and biological stability of this type of vaccine.
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Definition of a Security Value Determined by Limulus Amebocyte Lysate Assay Targeting the Recombinant Human Epidermal Growth FactorThe correlation between limulus amebocyte lysate (LAL) assay and rabbit pyrogen test (RPT) targeting recombinant human epidermal growth factor (rhEGF) as active molecule was assessed.
