Authors
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Configuring Manufacturing Operation Management ApplicationsAdopting single-use systems has implications for manufacturing execution systems, process data-analytics tools, and scheduling
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Methods for the Automated Manufacturing of an Autologous Dendritic-Cell ImmunotherapyThe author describes automated equipment that uses functionally closed disposables.
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Regulatory Requirements for Viral-Challenge Studies: Influenza Case StudyReview regulatory requirements and the use of viral-challenge studies in drug development.
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State of Quality and Compliance in the Biopharmaceutical IndustryHave FDA initiatives improved manufacturing quality?
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Single-Use Technology for Syringe FillingA novel approach to sterile drug product manufacturing uses a single-use assembly in a multi-product final filling suite with isolator technology.
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Single-Use Redundant FiltrationThe authors describe a new assembly for bulk and final drug product filling operations.
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Single-Use Redundant FiltrationThe authors describe a new assembly for bulk and final drug product filling operations.
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Biologics: Can There Be Abbreviated Applications, Generics, or Follow-On Products?In this question-and-answer discussion of "generic" biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule.
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Process Development and Spiking Studies for Virus Filtration of r-hFSHThis study on a recombinant human follicle stimulating hormone demonstrates the use of virus filters to reduce the risk of contamination.
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Training the Biopharma IndustryUsing a competency-based approach to effectively train biopharmaceutical industry staff.
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SEC in the Modern Downstream Purification ProcessRecent technological advances in the way biologic therapeutics are purified may bring size-exclusion chromatography back into the modern purification process.
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Using NGC System and Stain-Free Gel TechnologyTo maintain high purity with an untagged protein, consider protein purification workflow development using the Bio Rad NGC Chromatography System, prepacked EconoFit Columns, and Stain Free gel technology.
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Supplier-Change Management for Drug-Product ManufacturersAn effective supplier-initiated change management process is discussed.
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Single-Use Technology for Syringe FillingA novel approach to sterile drug product manufacturing uses a single-use assembly in a multi-product final filling suite with isolator technology.
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Single-Use Technology for Syringe FillingA novel approach to sterile drug product manufacturing uses a single-use assembly in a multi-product final filling suite with isolator technology.
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Driving Innovation in BiopharmaceuticalsThe biopharmaceutical industry must consider new ways to manage innovation, including how product data are handled.
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An Environmental Lifecycle Assessment of Single-Use and Conventional Process Technology: Comprehensive Environmental ImpactsAn environmental study of single-use process technology for biopharmaceutical manufacturing offers a comprehensive examination of environmental impacts across the full process train using lifecycle assessment.
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An Overview of Risk Assessment Strategies for Extractables and LeachablesApproaches for risk assessment of extractables and leachables.
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An Environmental Lifecycle Assessment of Single-Use and Conventional Process Technology: Comprehensive Environmental ImpactsAn environmental study of single-use process technology for biopharmaceutical manufacturing offers a comprehensive examination of environmental impacts across the full process train using lifecycle assessment.
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Extractables and Leachables: Best Practices to Ensure Patient SafetyThe author presents best practices for extractables and leachables.
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Process Development and Spiking Studies for Virus Filtration of r-hFSHThis study on a recombinant human follicle stimulating hormone demonstrates the use of virus filters to reduce the risk of contamination.
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Concentrating Feed—an Applicable Approach to Improve Antibody ProductionDifferent approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture are evaluated.
Latest:
Process Development and Spiking Studies for Virus Filtration of r-hFSHThis study on a recombinant human follicle stimulating hormone demonstrates the use of virus filters to reduce the risk of contamination.
