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Industry 1VQ Solutions: Change of Lot or Extension of Shelf-life of Reference StandardChange of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.
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Reducing Vulnerabilities in Upstream and Downstream Supply ChainsMakers of specialty biologics, gene therapies, and other personalized medicines are working to identify and reduce potential supply chain risks both upstream and downstream.
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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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Discovery to Commercialization: The Right Partnerships are Key to Streamlined Drug DevelopmentIn this rapidly changing environment, your choice of CDMO partner is critical. The right partnership can serve as your key to commercial success, while the wrong one can lead to costly delays, quality issues and compliance risks. To help you overcome your OSD challenges and drug product manufacturing challenges and streamline your journey to commercialization, our experts have developed an eBook to help you find the right CDMO for your project.
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Key Drivers to Overcome Obstacles in mAbs Formulation and Fill-FinishDespite selecting the right, compendial excipients for a balanced formulation, you may encounter obstacles that delay market deadlines. Learn how to streamline the formulation and fill-finish process with the right raw material selection, secure and efficient fluid pathway design, comprehensive regulatory support, and supply chain transparency.
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A Different CDMO Experience: Q&A With Scorpius’ President & COO Joe PayneJoe Payne, Scorpius BioManufacturing, comments on the unique needs of today's biopharmaceutical companies looking to develop and manufacture small-volume, early-stage large molecules.
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Getting under Our Skin: The Evolving Field of Transdermal DeliveryThe book is written for drug-delivery scientists experienced in the dermatological or transdermal fields.
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The ICH Q9 Revision and a Renewed Focus on Quality Risk Management FundamentalsThe ICH Q9 revision clarifies QRM implementation for the pharmaceutical industry and expands descriptions of methodology, formality, and risk-based decision making to provide the industry with a solid base from which to build their own QRM programs.
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Seven Trends Shaping the Future of Pharmaceutical Formulation DevelopmentEmerging new technologies and disruptive manufacturing concepts are providing new opportunities for pharmaceutical companies.
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Enhanced Bioavailability of Acalabrutinib ASD Tablets In-VivoThe pH effect encountered with oral oncology medication can be overcome with amorphous solid dispersions.
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Is Your Packaging Line Operating To Full Capacity?Overall Equipment Effectiveness has been shown to identify the root cause of inefficiencies.
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Seven Trends Shaping the Future of Pharmaceutical Formulation DevelopmentEmerging new technologies and disruptive manufacturing concepts are providing new opportunities for pharmaceutical companies.
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The Key Elements for Assay Transfer SuccessPartnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers that should continue in the future.
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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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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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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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Highly Efficient Olefin-Metathesis CatalystsThe authors describe the Piers' catalysts and detail latest progress in olefin-metathesis catalyst technology.
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The IMA Group at Achema 2022At ACHEMA 2022, the IMA Group will showcase its All-In-One Pharma range of solutions and projects aimed at sustainability and digitalization.
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Extractables and Leachables: An Overview of Emerging ChallengesExtractables and leachables are a growing concern for pharmaceutical manufacturers and regulatory bodies.
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High-Quality Glass Improves Confidence in Analytes MeasurementChoosing low-adsorption glass vials helps ensure detection accuracy.
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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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Key Factors in the Development of Data Analytics for Industrial Pharmaceutical EquipmentDigital maintenance solutions can help visualize the value and key activities provided by the equipment vendor from inception to utilization.
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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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How to Effectively Implement Pharma 4.0 TechnologiesGetting started with a PAT framework enables automation with digital technologies.
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Polymer Influence on the Rheological Properties of Co-Processed Microcrystalline Cellulose and Sodium CarboxymethylcelluloseIn this study, researchers evaluated the colloidal microcrystalline cellulose (cMCC) suspending agent—a co-processed material of microcrystalline cellulose and sodium carboxymethyl cellulose (NaCMC)—by using a representative pharmaceutical-grade commercial version of cMCC.
