Authors
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.
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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.
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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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Accelerated Delivery to a Development Candidate Enabled by RapidFire_MSWebinar Date/Time: Monday, March 27th at 11am EDT|8am PDT|4pm BST|5pm CEST
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Development of an Alternative Monoclonal Antibody Polishing StepMAb polishing using salt tolerant interaction membrane chromatography.
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Scale-up of Human Mesenchymal Stem Cells on Microcarriers in Suspension in a Single-use BioreactorDemonstration of large-scale stem-cell scale-up.
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Integration of a Single-Use Platform Process within an Innovative Facility DesignThe combination of single-use platform technology with modular facility construction is a template for flexible manufacturing.
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Optimizing Drug Delivery for Modern BiologicsThis article discusses potential opportunities to improve the patient experience through formulation and delivery device technologies.
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Scale-up of Human Mesenchymal Stem Cells on Microcarriers in Suspension in a Single-use BioreactorDemonstration of large-scale stem-cell scale-up.
