CLINICAL SUPPLY MANUFACTURING ARTICLES
Improving Governance And Compliance With Knowledge Management
Knowledge management — it’s not just a soulless exercise. In the last part of his series, Hirsh helps bridge the gap between compliance and business needs.
CLINICAL SUPPLY MANUFACTURING VIDEOS
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.
Tony Sampognaro, Director, CMC Project Management, Stoke Therapeutics, recalls a rather harrowing experience involving a CMO and Clinical Operations failure to communicate.
Understand how free trade zones work, and explore a flexible and cost efficient way to supply clinical trials in China and around the globe.
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-1413600685-lab-team-collaboration-computer-research]( "Reaching First-In-Human Trials Faster: Connect With The Right Partner")
Assessing outsourcing partners’ credentials in people, technology, supply chains, and integration will make all the difference as sponsors aim to streamline processes on the path to commercialization.
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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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![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.
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![iStock-1213895723-cold chain-packaging-logistics-storage]( "Overcoming Cell Therapy Supply Chain Challenges")
For the industry to realize the potential of cell and gene therapies (CGTs), we must develop improved solutions that reliably support the control and transport of critical CGT raw materials and products.
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![Vaccine Manufacturing GettyImages-1384850913]( "GxP Inventory Enhances Supply Chain For Global Specialty Biotech Firm")
Discover how the simplification and digitization of clinical supply chain operations enhanced transparency, lowered risks and expenses, and optimized efficiency.
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![WEST-ELAS LYO Lyotec-012 LREZ]( "Key Considerations For Selecting Fill/Finish Manufacturing Technologies")
Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.
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Handling development and manufacturing challenges for orphan drugs requires experience, expertise and scalable technologies, along with a flexible and agile supply chain.
