CLINICAL SUPPLY MANUFACTURING ARTICLES
Survey Findings: How Are IDMP Readiness Efforts Progressing?
ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.
CLINICAL SUPPLY MANUFACTURING VIDEOS
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.
Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.
Understand how free trade zones work, and explore a flexible and cost efficient way to supply clinical trials in China and around the globe.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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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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![Panademic Related Manufacturing Complications]( "Outsourcers Are Feeling Uneasy About Continuity Of Supply")
Find out how COVID-19 complications have picked up from the first year, with more outsourcers experiencing bigger obstacles when it comes to manufacturing, specifically with drug product.
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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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![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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![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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![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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![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.
