CLINICAL SUPPLY MANUFACTURING ARTICLES
Warning To U.S.-Based CDMOs: Don't Get Complacent
How could I not ask him for an opinion regarding our vigorously pursued editorials on the WuXi Apptec–BIOSECURE Act. After all, Reza Oliyai has outsourced a myriad of development and manufacturing services to hundreds of CDMOs around the world. He did so at Gilead for decades, and since as the CEO of his eponymous consulting company. His response did not disappoint.
CLINICAL SUPPLY MANUFACTURING VIDEOS
Tony Sampognaro, Director, CMC Project Management, Stoke Therapeutics, recalls a rather harrowing experience involving a CMO and Clinical Operations failure to communicate.
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.
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.
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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![Vaccine injectable vials and syringe GettyImages-1252804942]( "Developing Injectable Drug Placebo Formulations For Clinical Trials")
Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.
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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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![cdmo-drug-assembly-manual-GettyImages-1339603591]( "Practical Playbook For The Manual Assembly Of Combination Products")
Manual assembly plays a vital role in early‑phase combination product development. Learn how strong process design, collaboration, and quality controls help teams reduce risk, improve consistency, and move confidently toward later‑stage manufacturing.
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![GettyImages-155372946-cold-chain-cryopreservation-logistics]( "Cold Chain Services For Clinical Trial Success")
As innovative, complex therapeutics advance toward clinical trials, properly handling, storing, and packaging temperature-sensitive critical materials is essential to maintain product integrity.
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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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![GettyImages-1002000796-lab-research-scientist-development]( "Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials")
The Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.
