CLINICAL SUPPLY MANUFACTURING ARTICLES
2024 Trends In FDA Observations For Sterile Drug Manufacturers
This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?
CLINICAL SUPPLY MANUFACTURING VIDEOS
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
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.
Experts take you through the entire selection process for primary packaging components for lyophilization and provide aspects to consider for all relevant attributes.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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![iStock-136140244-lab-pharma-equipment-process]( "Speed To Market – API Large-Scale Commercial Manufacturing")
Learn how a top 20 US-based pharma company achieved more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection with the help of a CMO partner.
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![GettyImages-820427458 clinical trials]( "Ensure Seamless, Efficient Delivery Of Clinical Trial Materials Worldwide")
Drug discovery companies, CROs, and CDMOs are under pressure to find supply management solutions that ensure delivery of clinical trial materials while navigating complex study designs and the regulatory landscape.
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![iStock-1213895723-cold chain-packaging-logistics-storage]( "Overcoming Cell Therapy Supply Chain Challenges")
For the industry to realize the potential of cell and gene therapies (CGTs), we must develop improved solutions that reliably support the control and transport of critical CGT raw materials and products.
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![August-BTN-1-small]( "Desired Integrated Clinical Logistics Activities")
Learn why clinical labeling, clinical supply chain management, and storage and distribution of clinical trial materials received the most votes in a survey of 100 sponsors outsourcing clinical logistics.
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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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![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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![GettyImages-184945838-cold-chain-cryopreservation]( "Building A Global Cell And Gene Supply Chain Serving Personalized Medicine")
Clinical distribution paths can be fragile for a multitude of reasons, making it critical that pharmaceutical sponsors and their partners orchestrate supply chain logistics even before site initiation.
