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The Ideal PharmacopeiaThis position paper describes a model for the future that would provide appropriate standardization, facilitate drug registration and support regulatory agencies.
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Do emerging markets provide the answer to the pharmaceutical industry?The emerging markets represent an attractive investment opportunity for the pharmaceutical industry because of the countries' growing economies and unmet medical needs.
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Digitalization of QbD Risk AssessmentsQuality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. Their digital transformation can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
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Characterization of the Performance of Bin Blenders-Part 3 of 3: Cohesive PowdersIn this final part of a series of three articles, the results from experiments involving cohesive materials are discussed in terms of mixing performance, agglomerate comminution, and lubrication of powder mixtures.
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Integrated Approach Facilitates Inhalation Drug DevelopmentThe choice of delivery platform for inhaled drug products is contingent on API-related factors, as well as the development stage of the product.
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Considerations for Monoclonal Antibody Bioprocess and Manufacturing ValidationRegulatory, analytical, and process concerns must be taken into account.
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Overcoming Engineering Challenges to Enable Commercial Scale mRNA Vaccine ManufacturingThis article provides an overview of solutions to address key challenges facing vaccine developers or CDMOs wishing to build their own commercial-scale mRNA production facilities.
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High-Growth Microbial Fermentation for the Manufacture of BiologicsChallenges in fermentation can be addressed through equipment changes, facility design, and process development.
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Science, Empiricism, and Off-label UseWas FDA's decision to issue a draft guidance on of-label information, amidst Congressional scrutiny, the right thing to do?
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Needle-Free InjectionNeedle-free injection technologies have been developed for injecting liquid formulations, as well as injecting drugs and vaccines in a solid dosage form.
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Formulation of Sustained-Release Ketorolac Tromethamine PelletsThe authors evaluated the effect of polymer composition on the drug-release profile and the effect of storage conditions on dissolution characteristics.
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Microneedle Array Patch InnovationsKindeva’s microneedle array patch platforms for solid and liquid APIs have the potential to deliver far-reaching clinical, environmental, and usability benefits.
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Understanding Concomitant Components in Pharmaceutical ExcipientsViewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.
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Restructuring Method Transfer Through Global SitesMethod-transfer kits help simplify analytical method transfer for global site certifications.
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Process Patent Protection: Characterizing Synthetic Pathways by Stable-Isotopic MeasurementsThe authors describe the methods by which precise analyses of stable-isotopic abundances can be used in security and forensic applications for pharmaceutical materials. These methods include product and process authentication of raw materials, pharmaceutical intermediates, drug substances, formulated drug products, and synthetic pathways. Collectively, these methods can be used to investigate and mitigate patent infringement. In the future, more complete examples will be presented containing full isotopic results and the application of the methods described in this article.
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Application Note: Maintaining Batch-to-Batch ConsistencyProduct variability from biopharmaceutical manufacturing to storage can significantly impact the safety and efficacy of batch-to-batch products during clinical use.
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Supplementary Handwashing Techniques to Improve Hand HygieneA fluorescence test method was used to visually evaluate handwashing efficacy. Difficult-to-clean areas on skin such as skin folds and webbing between fingers were identified; specific washing techniques to address problem areas are proposed.
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BENEO galenIQ™BENEO produces galenIQ™, a water-soluble filler and binder. galenIQ™ has a sweetness and taste profile similar to sucrose, therefore it’s used to improve palatability of bitter-tasting active pharmaceutical ingredients and plant extracts.
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Considerations for Monoclonal Antibody Bioprocess and Manufacturing ValidationRegulatory, analytical, and process concerns must be taken into account.
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The Role of Separation Techniques in the Analysis of mRNA Therapeutic Drug Substances and Drug ProductsThis article reviews a range of techniques available for separative analysis of mRNA therapeutics, their associated impurities, and delivery vehicles.
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Harnessing Predictive Simulation to Improve MixingPredictive computational methods are finding wider use in pharmaceutical solid dosage development, particularly in mixing and blending, to improve tech transfer and equipment selection, and speed the acquisition of process understanding.
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Best Practices for Designing and Building a Pharmaceutical Manufacturing FacilityFor drug sponsors that are considering building their own manufacturing facilities, an expert project team is crucial.
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Drug Substance Starting Material SelectionThe authors review the current regulatory framework for the selection of drug substance starting materials.
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Nanotechnology: A lifeline for drying pharma pipelines?Pharmaceutical Technology Europe spoke with experts about the developments that have shaped the nanotechnology industry today and the benefits that this technology has to offer the pharmaceutical industry, which remain largely untapped.
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A bioanalytical discovery strategy for fast and flexible decision makingWebinar Date/Time: Wed, Oct 11, 2023 11:00 AM EDT
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Current Trends in Host Cell Protein Detection for Biologics ManufacturingIn this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.
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Pharmacovigilance Under Scrutiny: Why Companies are Falling ShortDespite pharmacovigilance legislation being in place for nearly a decade, many companies are still struggling to fulfill obligations.
