CLINICAL SUPPLY MANUFACTURING ARTICLES
Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs
Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.
CLINICAL SUPPLY MANUFACTURING VIDEOS
Scale your biologic fill-finish from vials to autoinjectors without disruption. See how integrated device assembly capabilities support every clinical phase through commercialization.
If you are in the process of developing a complex or sensitive injectable drug, learn about containment solutions to mitigate your risks and help you get your drug to the patient faster.
Early planning mitigates risk by avoiding stock outs and study delays, minimizing waste with optimized inventory, and forecasting demand to facilitate robust supply planning.
Tony Sampognaro, Director, CMC Project Management, Stoke Therapeutics, recalls a rather harrowing experience involving a CMO and Clinical Operations failure to communicate.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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![development-drug-manufacturing-GettyImages-2213157127 (1)]( "Expertise And Transparency Drive A Distinct Development Journey")
Coordinated expertise, real‑time visibility, and clear communication support smoother development, manufacturing, and clinical supply. Strong alignment improves predictability and lowers risk.
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![accuracy-in-drug-development-GettyImages-2249698250]( "GMP Clinical Storage Strategies for Today's Complex Trials")
Temperature‑sensitive therapies need more than basic freezer space. Purpose‑built GMP storage protects product integrity, supports compliance, and adds flexibility as trial complexity grows.
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![GettyImages-1299873218-lab]( "Expertise, Flexibility In Lipid Nanoparticle Clinical Manufacturing")
Explore the unique capabilities at a Vancouver, Canada site for clinical-scale manufacture of lipid nanoparticles (LNPs).
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![GettyImages-1298788278 drug manufacturing]( "GxP Inventory Solution Improves Clinical IP Efficiency And Compliance")
Learn how this biopharmaceutical research sponsor was able to centralize and digitalize the processes involved in clinical supply production through distribution using GxP Inventory.
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Handling development and manufacturing challenges for orphan drugs requires experience, expertise and scalable technologies, along with a flexible and agile supply chain.
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![GettyImages-1070902452-planning-tracking-packaging-shipment]( "Winning The Race To FPI With Early Randomization And Trial Supply Management")
Learn why the ability to get investigational products to sites, and appropriately store them, is not a given – and this oversight can have serious consequences.
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![WEST-ELAS LYO Lyotec-012 LREZ]( "Key Considerations For Selecting Fill/Finish Manufacturing Technologies")
Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.
