CLINICAL SUPPLY MANUFACTURING ARTICLES
Comparability Considerations For mRNA Product Development
Given the mRNA-based products' variability and unique challenges, you may need to modify the standard comparability approach. Let’s discuss strategies for any development stage.
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.
See how a cutting-edge, multi-purpose isolator line delivers high-speed, precision fill/finish. This flexible technology supports a diverse range injectable therapies.
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
Early planning mitigates risk by avoiding stock outs and study delays, minimizing waste with optimized inventory, and forecasting demand to facilitate robust supply planning.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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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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![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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![Microscope of cell, Embryonic stem cell]( "Optimizing Autologous Cell Therapy Clinical Trials")
Delve into four articles regarding dissecting the critical resources, processes, and key stakeholders essential for the successful completion of an ACT clinical trial.
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![Singota-DSC03221]( "Developmental Testing Of IV Solutions")
As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.
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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-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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![Vaccine injectable vials and syringe GettyImages-1252804942]( "Packaging And Containment: Get Your Products To Market Faster")
Learn more about why focusing on packaging solutions early on can keep development on track, help you meet milestones, and get your product to market faster.
