Authors
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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.
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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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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.
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Achieving Commercial Readiness: A Five-Step Program Speeds CommercializationCongratulations - your emerging biotechnology company is within sight of its first Biological License Application (BLA). This is the culmination of years of research and clinical development.
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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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Ice Fog as a Means to Induce Uniform Ice Nucleation During Lyophilization (Peer Reviewed)The authors describe a novel means to control ice nucleation using a sterile cryogenic ice fog.
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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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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the LifecycleThis series presents a practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three stages of the process validation lifecycle. In Parts I and II, risk analysis and process characterization studies were used to assign criticality risk levels to critical quality attributes and critical process parameters, and the concept of a continuum of criticality was established. In Part III, the author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
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Connecting QbD, Knowledge Management, and Supplier Quality ManagementUnderstanding overall supplier capability versus the critical-to-quality attributes of your product can reduce both risk and cost.
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Development of an Alternative Monoclonal Antibody Polishing StepMAb polishing using salt tolerant interaction membrane chromatography.
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How to Manage Effective Leadership when Change is the Only ConstantA disciplined approach to changing behavior can achieve change agility.
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Vaccine Packaging at the Clinical Interface of Vaccine, Healthcare Worker, and PatientPackaging vaccines using prefilled syringes can increase dosing efficiency, reduce costs, and improve patient safety. This article is part of a special section on vaccines.
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Saving the Next Generation of Regulatory ScientistsNew educational programs are key to the industry's future and to safe, available drugs.
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Recombinant Albumin Facilitates Formulation Design of Stable Drug ProductsRecombinant albumin can stabilize a drug product and assist in API release.
