CLINICAL SUPPLY MANUFACTURING ARTICLES
10 Ways To Speed Up CMC In Early-Stage Drug Product Development
The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.
CLINICAL SUPPLY MANUFACTURING VIDEOS
Experts take you through the entire selection process for primary packaging components for lyophilization and provide aspects to consider for all relevant attributes.
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
Scale your biologic fill-finish from vials to autoinjectors without disruption. See how integrated device assembly capabilities support every clinical phase through commercialization.
Expert speakers discuss current operational obstacles and explore strategic solutions to optimize a supply chain strategy in the years ahead.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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![West_GCApp_MG (person picking up container)]( "Understanding Injectable Drug Container Closure Systems")
Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.
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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_CZ Insert Needle 115860aw 11569_RGB_2]( "A Practical Packaging Components Checklist For Emerging Biotechs")
A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.
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![Microscope of cell, Embryonic stem cell]( "Optimizing Autologous Cell Therapy Clinical Trials")
Delve into four articles regarding dissecting the critical resources, processes, and key stakeholders essential for the successful completion of an ACT clinical trial.
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![Laptop clinical trials iStock-653839742]( "What Are Decentralized Clinical Trials (DCTs)?")
Discover how DCTs leverage “virtual” tools, such as telemedicine, sensory-based technologies, wearable medical devices, and direct delivery of study drugs and materials to patients’ homes.
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![iStock-486571129-supply-chain-logistics-packaging]( "Solving Logistic Complexities In The Era Of Personalized Medicine")
Examine how the next generation of therapies is disrupting supply chain logistics and explore solutions for the complexities within cell and gene therapies.
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![Ampoule Aseptic Filling GettyImages-1490244818]( "Advantages Of Robotic Aseptic Processing")
Examine the robotic technologies poised to increase manufacturing flexibility and efficiency while minimizing risk when bringing biologics to market.
