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Developing a MAb Aggregate Removal Step by High Throughput Process DevelopmentHTPD allows rapid screening of chromatographic parameters.
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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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Development of an Alternative Monoclonal Antibody Polishing StepMAb polishing using salt tolerant interaction membrane chromatography.
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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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Partial Replacement of Chemically Defined Media with Plant-Derived Protein HydrolysatesPlant-derived hydrolysates can be used as valuable and practical tools to improve cell culture performance.
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Sterilizing Filtration of Adjuvanted Vaccines: Ensuring Successful Filter QualificationFilterability and bacterial retention must be verified very early in process development to ensure successful sterilizing filtration validation.
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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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Cost of Goods Modeling and Quality by Design for Developing Cost-Effective ProcessesCombine cost analyses with QbD to improve operations and lower costs.
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Optimizing Vaccine Adjuvant FiltrationThe viscosity of oily emulsions can reduce filter capacity and bacterial retention.
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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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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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Biopharmaceutical Facility Cleaning Validation Using the Total Organic Carbon TestCase studies show TOC is effective for cleaning validation.
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Advances in Monoclonal Antibody PurificationNew technologies and adaptations of existing technologies can improve platform processes.
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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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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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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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Balancing Media Development with Patient SafetyThe quest for increased productivity and better process control combined with patient safety has encouraged biopharmaceutical companies to use chemically defined media for cell culture.
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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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Managing Cell Line Instability and Its Impact During Cell Line DevelopmentBy considering stability as part of the cell line selection and cell banking paradigm, we can ensure that instability problems are not observed during clinical or commercial manufacturing.
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A Generic Growth Test Method for Improving Quality Control of Disposables in Industrial Cell CultureQuality control for disposable-bags
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Advancing Adjuvants and Vaccine Delivery Systems for Better Vaccination StrategiesThis article presents ongoing research at VIDO-InterVac for the development of safer and more effective adjuvants. These include adjuvants that stimulate innate immunity in the body and combination adjuvants.
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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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Production Strategies for Antibody Fragment TherapeuticsMicrobial systems such as E. Coli and yeasts are most effective for producing antibody fragments.
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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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Robust Experimental Strategies for Improving Upstream ProductivityIdentify the best experimentation methods for the data you need.
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Characterizing the Formulation Design SpaceDesign of experiments is a valuable tool for identifying aspects of a formulation that are critical to product quality.
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The Proper Use of 47-mm Flat Disc Filters in Filter Sizing StudiesWhy staining is crucial in flow decay studies.
