CLINICAL SUPPLY MANUFACTURING ARTICLES
July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.
CLINICAL SUPPLY MANUFACTURING VIDEOS
Early planning mitigates risk by avoiding stock outs and study delays, minimizing waste with optimized inventory, and forecasting demand to facilitate robust supply planning.
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.
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.
Experts take you through the entire selection process for primary packaging components for lyophilization and provide aspects to consider for all relevant attributes.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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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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![GettyImages-1299873218-lab]( "Expertise, Flexibility In Lipid Nanoparticle Clinical Manufacturing")
Explore the unique capabilities at a Vancouver, Canada site for clinical-scale manufacture of lipid nanoparticles (LNPs).
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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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![pharma-manufacturing- GettyImages-2274021643]( "How Specialized CDMOs Help Advance Programs From Concept To Clinic")
Integrated drug development streamlines manufacturing, analytics, and supply to cut risk and speed timelines. Inhalation advances and flexible partnerships help therapies reach commercialization faster.
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![iStock-1293772969-lab-microscope-scientist-research]( "Clinical Manufacturing: What It Is And How It Works")
Clinical manufacturing is a specialized form of pharmaceutical manufacturing focused on producing drugs for clinical research. How does it work and how is it different from commercial manufacturing?
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![GettyImages-1327568875-technology-clinical trials-computer-medicine-research]( "A Smart Solution To Clinical Supply Management")
Delve into a solution that ensures the efficient delivery of trial materials worldwide, while navigating the challenges of more complex study designs and the ever-evolving regulatory landscape.
