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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.
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Polishing Complex Therapeutic ProteinsA new downstream purification platform using a salt-tolerant membrane adsorber.
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Corrective and Preventative Action Programs: A Mechanism of ControlAn effective CAPA plan provides a mechanism for responding to the unexpected.
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Using Metabolic Profiling Technology to Advance Cell Culture DevelopmentThrough metabolomics, the metabolic underpinnings of cellular changes can be rapidly pinpointed, directing process development scientists to key areas for cell culture optimization.
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Developing an Automatically Controlled Feeding Process in an E. coli Fermentation Process for Recombinant Protein ProductionAn exponential feeding strategy coupled with automation doubled protein yields while reducing fermentation time by 25%.
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Freeze Bulk Bags: A Case Study in Disposables ImplementationGenentech's evaluation of single-use technologies for bulk freeze-thaw, storage, and transportation.
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Intensification of a Chromatography PlatformThe authors present a shift toward more integrated purification processes.
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Harvesting the Benefits of LEAN in Biopharmaceutical ManufacturingA step-by-step approach is essential for successful implementation.
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Five Things Every Biotech Company Must Know About BiosimilarsThe new US legislation will forever alter the commercial landscape for biologics.
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Safe Freeze–Thaw of Protein Drug Products: A QbD ApproachApply a DoE strategy to test several formulations in parallel.
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The Proper Use of 47-mm Flat Disc Filters in Filter Sizing StudiesWhy staining is crucial in flow decay studies.
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Integrating CMC Document Preparation into the Development Process for Vaccine INDsVaccine process development is complex, and so are the documents required before clinical trials begin. Technical writers and editors can effectively coordinate the timely authoring, reviewing, and auditing of regulatory documents, minimizing filing delays.
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The Effect of Thermal Cycling on Clamp-Type FittingsHow to control compressive loads on seal materials.
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Analytical Tools for Process and Product CharacterizationSelect the best approach to determine critical quality attributes.
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Biopharmaceutical Facility Cleaning Validation Using the Total Organic Carbon TestCase studies show TOC is effective for cleaning validation.
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Best Practices for Microbial Fermenter Equipment CharacterizationWet testing of microbial fermenters allows for a greater understanding of the equipment's capabilities.
