Authors
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Viewpoint: Data Integrity and Its Ties with Personal IntegrityThe root cause of the most serious integrity issues has generally been a lapse of ethical behavior on the part of an individual.
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Converging InformationTechnology & Automation TeamsGetting IT, engineering, and manufacturing on the same page requires a delicate balance.
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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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Industry 1VQ Solutions: Replace Identity (ID) Testing of Incoming Liquid Drug Substance with ID by Visual VerificationA Post Approval Change (PAC) to replace identity (ID) testing of incoming liquid drug substance with ID by visual inspection is considered a low risk provided questioned listed in this example have been answered favorably. In that case the PAC can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.
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Viewpoint: Precompetitive Collaboration Drives Pharma Industry InnovationThe IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.
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Continuous Mixing of Solid Dosage Forms via Hot-Melt ExtrusionThe author describes the benefits, processes, and practicality of using hot-melt extrusion to mix active pharmaceutical ingredients with pharmaceutical-grade polymers.
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Online TOC Comparison: Sensors and AnalyzersThis application note shows how Sievers TOC analyzers and common sensors in the industry recover 11 different compounds most often used in water and product analysis.
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Analytical Strategies for Cell and Gene Therapy DevelopmentDeveloping bioassay methods requires a new approach for cell and gene therapy drug development.
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E&L Analytical Testing ConsiderationsE&L analytical testing methods can be determined through pointed consideration of the differences small- and large-molecule drug products.
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HME vs Spray Drying: A Comparison of Saturated Solubility EnhancementHot Melt Extrusion (HME) is a widely utilized pharmaceutical technique designed to enhance the bioavailability of poorly soluble drugs through solid molecular dispersions. Effective analytical characterization plays a critical role in the efficient development of HME formulations.
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Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based StrategiesMany biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
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Guidelines for Selecting Normal Flow FiltersProper selection of normal flow filters leads to increased process efficiency from early phase product development through to full-scale biopharmaceutical production.
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Obtaining simultaneous multiple dissolution profiles of solid oral dosage formulationsTesting the dissolution rates of a pharmaceutical formulation (also known as in vitro availability) aids drug quality control and is a compulsory requirement of the British, European and US pharmacopoeias.
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Development of Orally Disintegrating Tablets Based on a New ExcipientThe authors examine the effectiveness of an excipient comprised of mannitol, polyvinyl acetate, and crospovidone using model actives loperamide hydrogen chloride and caffeine.
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Improving Solid Dosage Forms With Dry GranulationAlthough tablet manufacture is traditionally a batchbased wet granulation process, there are many advantages to be gained by adopting dry granulation, including lower costs and increased yields.
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Value-Added Medicines: From Development to ApprovalWebinar Date/Time: Tue, Sep 24, 2024 10:00 AM EDT 7am PDT | 3pm BST | 4pm CEST
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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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Assessing Data Integrity Risks in an R&D EnvironmentA data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.
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Patentability Considerations for Antibody-Related InventionsStringent patentability requirements present a challenge to obtaining broad-based antibody claims, so companies should develop a strategy based on multiple reinforcing layers of protection.
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Converting Injectable Therapies to Combination Drug-Device ProductsThe author describes how to seize market opportunities while navigating the requirements of both drug therapies and delivery devices.
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Data Integrity Considerations for Vendor-Generated Data Associated with Analytical TestingSponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.
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A Catalyst for Environmental ConsciousnessA recent book shows the links between synthesis, catalysis, and environmental protection.
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ICH Q6B for AnalyticsICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products.
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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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Accelerating Biopharma Development and Manufacturing through CDMOs and CGTWebinar Date/Time: Thu, Jul 20, 2023 11:00 AM EDT
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Selecting a freeze dryerThe most important consideration when choosing a freeze dryer is to ensure the system is fit for both today's applications and future needs.
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Key Considerations When Repositioning a Known Drug for Inhalation TherapyCreating an inhaled formulation is one way in which improved efficacy or added value can be achieved in projects to repurpose or reposition existing drugs.
