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Virtualized Infrastructure Takes Hold in Pharma Process AutomationVirtualization has been mainstream in information technology (IT) for decades.
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Virtualized Infrastructure Takes Hold in Pharma Process AutomationVirtualization has been mainstream in information technology (IT) for decades.
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Disposable Technology versus Traditional Stainless Steel--When Time Means MoneyThe use of disposables requires careful consideration and planning.
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Controlled Nucleation for a Monoclonal Antibody Formulation—A Case StudyThis study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.
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Controlled Nucleation for a Monoclonal Antibody Formulation—A Case StudyThis study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.
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QbD and PAT: A Marriage Made in Heaven?The basic principle behind QbD is that quality should be built into a product with an understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks.
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Determining Protein Oxidation Induced During Fill-Finish OperationsThe effect of absorbed vapor-phase hydrogen peroxide on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide.
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Tips for Automated WashingCareful choice of wash-water parameters and attention to water quality and basket loading are important for optimal cleaning.
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Determining Protein Oxidation Induced During Fill-Finish OperationsThe effect of absorbed vapor-phase hydrogen peroxide on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide.
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Determining Protein Oxidation Induced During Fill-Finish OperationsThe effect of absorbed vapor-phase hydrogen peroxide on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide.
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Optimizing the Sterilization of Liquids in Sealed Containerssterilization approach-cycles controlled by differential pressure-is described.
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Determining Protein Oxidation Induced During Fill-Finish OperationsThe effect of absorbed vapor-phase hydrogen peroxide on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide.
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Achieving and Maintaining Compliance Using Continuous Monitoring SystemsChallenges encountered when implementing a continuous monitoring system are reviewed.
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A Practical Guide to Hot-Melt Extrusion Scale-Up for Pharmaceutical ApplicationsThe author discusses various aspects of the hot-melt extrusion process and outlines a practical approach to scale-up.
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A Quality-by-Design Approach to Optimize In-Process Curing of EUDRAGIT NM 30 DA study investigated the influence and correlation of critical process parameters for the optimization of in-process curing.
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Using Modular Systems in Solid-Dosage ManufacturingThe authors describe how modular systems can be applied to continuous solid-dosage and nutraceutical manufacturing.
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Multiple Reaction Monitoring–Mass Spectrometry for Biopharmaceutical AnalysisThe authors describe two applications of a modified mass-spectrometry (MS) method, multiple reaction monitoring (MRM-MS), in biopharmaceutical analysis.
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Multiple Reaction Monitoring–Mass Spectrometry for Biopharmaceutical AnalysisThe authors describe two applications of a modified mass-spectrometry (MS) method, multiple reaction monitoring (MRM-MS), in biopharmaceutical analysis.
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Multiple Reaction Monitoring–Mass Spectrometry for Biopharmaceutical AnalysisThe authors describe two applications of a modified mass-spectrometry (MS) method, multiple reaction monitoring (MRM-MS), in biopharmaceutical analysis.
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Multiple Reaction Monitoring–Mass Spectrometry for Biopharmaceutical AnalysisThe authors describe two applications of a modified mass-spectrometry (MS) method, multiple reaction monitoring (MRM-MS), in biopharmaceutical analysis.
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Multiple Reaction Monitoring–Mass Spectrometry for Biopharmaceutical AnalysisThe authors describe two applications of a modified mass-spectrometry (MS) method, multiple reaction monitoring (MRM-MS), in biopharmaceutical analysis.
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Multiple Reaction Monitoring–Mass Spectrometry for Biopharmaceutical AnalysisThe authors describe two applications of a modified mass-spectrometry (MS) method, multiple reaction monitoring (MRM-MS), in biopharmaceutical analysis.
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Multiple Reaction Monitoring–Mass Spectrometry for Biopharmaceutical AnalysisThe authors describe two applications of a modified mass-spectrometry (MS) method, multiple reaction monitoring (MRM-MS), in biopharmaceutical analysis.
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Ultra-High-Speed Analysis of Ibuprofen Using HPLCThe authors present an analysis of ibuprofen based on United States Pharmacopeia General Chapter “Chromatography” using high-performance liquid chromatography.
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Simultaneous Quantitative and Qualitative Measurements in Drug-Metabolism InvestigationsThis article presents the successful analysis of metabolic products from microsomal incubations of a common pharmaceutical compound.
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Characterization with Atomic Force Microscopy, Topographic, and 3D RamanThe authors describe how a combination of imaging techniques can be used to provide topographic and chemical information to characterize a sample.
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Advanced Aseptic Liquid Processing TechnologyWeiler Engineering, Inc.’s corporate focus is to provide advanced aseptic liquid processing technology through the application of customized ASEP-TECH® Blow/Fill/Seal machinery and services. Serving the pharmaceutical industry has been Weiler’s core business for more than 50 years. Weiler focuses on the patient and strives to provide the safest sterile aseptic packaging process for pharmaceutical liquids. This concept is based on studying and implementing learned technological advances driven by Science.
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Sterilization Effects on Elastomers in Sterile Parenteral Drug ProductsThis article looks at data gathered from several studies of a widely marketed chlorobutyl rubber formulation used for vial stoppers and prefilled syringes.
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Validating and Implementing a Rapid Sterility Testing MethodTraditional sterility testing methods can take 14 days or longer to complete, so a growing number of pharmaceutical manufacturers and quality control
