CLINICAL SUPPLY MANUFACTURING ARTICLES
Vendor/Supplier Management To Maintain A Drug's Safety Profile In End-To-End Supply Chain Planning
FDA 21 CFR 211 requires vendor qualification as a part of the validation process and EU GxP requirements expect robust vendor management, and we expect regulators to issue firmer guidance sooner rather than later. Don't let your pharma/biotech fall short.
CLINICAL SUPPLY MANUFACTURING VIDEOS
See how a cutting-edge, multi-purpose isolator line delivers high-speed, precision fill/finish. This flexible technology supports a diverse range injectable therapies.
Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.
Early planning mitigates risk by avoiding stock outs and study delays, minimizing waste with optimized inventory, and forecasting demand to facilitate robust supply planning.
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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![GettyImages-1127105013-lab-computer-research-scientist]( "Designing An Optimal APAC Clinical Supply Chain")
Gain the knowledge and skills needed to effectively navigate the complex clinical supply distribution landscape within this important and rapidly growing region.
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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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![BO 2 - GC_App_^CZ vial with stopper and seal stack up]( "Bringing A Biosimilar For Oncology To Market: Injectable Packaging From Early Development To Commercialization")
While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.
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![Singota]( "Faster From Formulation To Fill/Finish")
Optimize your speed to clinic by securing a development and aseptic fill/finish partner to support your applications with the right manufacturing equipment, communications, and SOPs.
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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.
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![DD 2 - 2mL_10mL_Vials_Tubs_Capped]( "Safeguarding Cell Therapy Cryopreservation: Primary Containers")
Review different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.
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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.
