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
Christina Yi, Chief Operating Officer at Vaxxinity, vaccine commecialization expert Kimberly Murphy, and Valneva Chief Medical Officer Dr. Juan Carlos Jaramillo discuss the biggest manufacturing challenges they face as they work quickly to develop clinical supply of next-generation vaccines and commercial supply of existing product. The supply chain proves chief among those challenges. In this segment of our recent BioProcess Online Live! event Manufacturing Vaccines On COVID's Coattails, the two discuss how these challenges have impacted timelines, how they're solving those challenges at Vaxxinity and Valneva, and lessons learned during the COVID-19 pandemic that they'll carry into the future.
Susan Dexter, Chief Technical Officer, Sonnet BioTherapeutics, describes the good choices she made, and one not-so-good choice, in trying to untie a knotted supply chain.
Expert speakers discuss current operational obstacles and explore strategic solutions to optimize a supply chain strategy in the years ahead.
Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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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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![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-184945838-cold-chain-cryopreservation]( "Prepping For Commercialization Through Supply Chain Logistics")
While cell and gene therapies are bringing new hope to patients experiencing rare and serious diseases, uncover how they're disrupting the biopharma market in new and challenging ways.
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![cdmo-drug-assembly-manual-GettyImages-1339603591]( "Manual Assembly Strategies For Early‑Phase Combination Product Supply")
Early‑phase combination products rely on manual assembly. Clear process design, quality controls, and collaboration help clinical supply teams reduce risk and maintain trial‑ready flexibility.
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![GettyImages-1467240751 patient doctor]( "Delivering Apheresis Treatment From The USA To The UK Within 24 Hours")
The goal was to perform next-day collection of temperature-sensitive tumor material for an urgent patient treatment. A flexible mitigation strategy was essential to manage short turnaround.
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![GettyImages-1189150676-Medicinal_Marijuana_Cannabis_ControlledSubstance]( "Controlled Substances In Clinical Trials")
Handling controlled substances presents layers of complexity. Partnering with an experienced CDMO is essential for managing scheduled materials during clinical studies.
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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.
