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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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Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug DevelopmentExtrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
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POLYOX™ Polyethylene Oxide Essentials: An Expert Guide to Polymer Properties and Drug FormulationWebinar Date/Time: Tue, Nov 19, 2024 11:00 AM EST
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Detecting GMP failuresAn effective quality management system will identify the root cause of non-conformances and put measures in place to ensure that they do not recur, but is the pharmaceutical industry choosing the right methods to make sure this happens?
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Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug DevelopmentExtrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
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Importance of a Hybrid Approach to Manufacturing and SourcingBradley Grobler, Vice President of Sales, Pharma & Biopharma Europe, describes how Actylis meets global demands for (bio)pharmaceutical development and manufacturing programs during CPhI 2023.
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IPS Tech TalksWhether you are considering a new facility build or a facility upgrade, IPS has expert teams using the latest technologies to bring you strategies that provide cost certainty, real-time updates, and successful construction project management.
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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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The Impact of SARS-CoV-2 on Biomanufacturing OperationsThis article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.
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Formulation and Evaluation of Enteric Coated Aspirin CapsulesIn this study, the ability of the enteric coating to properly seal and protect capsule contents through various analytical tests was analyzed using dissolution vessels containing acidic media.
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Viral Vector API Characterization of Product-Related ImpuritiesFDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.
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Optimizing the Total Cost of Ownership for APIsAll members of the pharmaceutical supply chain must implement reliable sourcing and manufacturing strategies that balance quality and costs to ensure the uninterrupted supply of high-quality medicines to patients worldwide.
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Discover The Business Value of TrakSYS™Through in-depth interviews with leading global manufacturers, the International Data Center (IDC) established the impact TrakSYS has on manufacturing operations.
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Using Modified QbD to Develop a Novel Pediatric Formulation of EzogabineThe epilepsy treatment, Potiga, has been used off-label to treat specific types of epilepsy in some children. However, it has never been formally evaluated in pediatric clinical trials. Using a modified QbD approach, the authors have developed a granular formulation suitable for use in clinical trials involving infants and children.
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Accelerating Project Delivery with a Lean Alternative to DBBLean delivery offers a promising solution to supply and manufacturing bottlenecks by integrating project teams early on and widening the team’s field of view.
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Supply Chain Challenges Creating Hurdles to COVID-19 Vaccine ProductionThe availability of materials is a critical factor when it comes to vaccine capacity.
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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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Accelerating Biopharma Development and Manufacturing through CDMOs and CGTWebinar Date/Time: Thu, Jul 20, 2023 11:00 AM EDT
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Determining Low PPB Levels of Nitrite in Polymeric ExcipientsIn this paper, the authors introduce a method that combines ion exchange chromatography with an easier-to-perform, simpler one-step post-column derivatization that is selective to nitrite and visible spectrophotometric detection to allow high sample loading volumes without affecting resolution.
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A Big Impact: Trends Shaping Small-Molecule APIs, Excipients, and FormulationsWebinar Date/Time: Thursday, September 21, 2023 at 11am ET | 10am CT | 8am PT | 4 pm BST
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Nitrosamides–Should They Be Treated the Same as Nitrosamines?The authors discuss the differences in mechanism of activation of N-nitrosamides versus N-nitrosamines and the fact that they should not be treated the same.
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Viral Vector API Characterization of Product-Related ImpuritiesFDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.
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Understanding Pharmaceutical Compounding from Multiple PerspectivesMeeting patient needs and achieving high quality are common goals for all stakeholders.
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The Quest for Cleanroom FlexibilityContextualizing what type of flexibility is needed is paramount when considering cleanroom design.
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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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Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
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Understanding Excipient Characteristics to Ensure Robust Continuous ManufacturingKey information is needed for excipients and their potential impact on continuous manufacturing processes.
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Integrated Approaches to the Data LifecycleAn integrated approach to the data lifecycle is key to successful digital transformation.
