Authors
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Analytical Techniques for Oral Solid Dosage FormulationAnalytical technologies must accurately identify and measure the critical material attributes of APIs and excipients.
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Using Polymers for More Efficient Hot-Melt Extrusion and Spray DryingNew cellulosic polymers have been shown to improve solubility in these key amorphous solid dispersion processes.
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Rapid Screening for Elemental Impurities using ICP-MSThe authors describe a rapid, single-point calibration approach for ICP–MS analysis of raw materials used in drug product manufacturing.
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Validation of a Multiplex Bead-Based AssayThe authors present a validation study of an analytical method for the simultaneous determination of nine human cytokines in human K2-EDTA plasma.
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Keeping Up with Biologics AdvancesThe European Pharmacopoeia addresses the need for monographs for biologicals to keep pace with recent analytical technology advances.
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Best Practice: Developing Drugs that are Highly PotentHighly potent or cytotoxic drugs require special handling
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Developing an Orally Inhaled Dry Powder Formulation—A Complex Itinerary and a Technological ChallengeSuccessful drug delivery via a dry powder inhaler is determined by the API physicochemical properties, the formulation composition and process, the device and operating conditions, the patient–device relationship, the environmental variables, and ultimately, patient compliance.
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Breaking Down Pharma BordersWith the Indian pharmaceutical industry on the rise, manufacturing businesses are working together with European and American partners to harness their longstanding experience and reputation in cleanroom manufacturing for a broader pharmaceutical manufacturing marketplace.
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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.
Latest:
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.
