CLINICAL SUPPLY MANUFACTURING ARTICLES
Warning To U.S.-Based CDMOs: Don't Get Complacent
How could I not ask him for an opinion regarding our vigorously pursued editorials on the WuXi Apptec–BIOSECURE Act. After all, Reza Oliyai has outsourced a myriad of development and manufacturing services to hundreds of CDMOs around the world. He did so at Gilead for decades, and since as the CEO of his eponymous consulting company. His response did not disappoint.
CLINICAL SUPPLY MANUFACTURING VIDEOS
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.
This session presents a risk-based framework for high-potency micronisation, illustrated through a practical case study that spans development to commercial scale.
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.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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![Scientist syringe vaccine GettyImages-1351831059]( "Overcome The Supply Chain Complexities Of Vaccine Development")
Explore the industry impact of rapidly evolving vaccinology, the power of next-gen science and technology, and how finding the right supply chain partner has never been more essential.
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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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![pharma-spray-drying-GettyImages-1746637448]( "How CDMOs Deliver Precision and Scale in Pharma Spray Drying")
Spray drying depends on precise control, scalable methods, and solid quality systems. Strong design and GMP‑aligned execution help reduce risk and move complex compounds forward efficiently.
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![Pharmaceutical-Drug-Manufacturing-GettyImages-1405788565]( "Specializing In Small And Early-Stage Partners, Not Just Small Batches")
Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.
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![Contract Manufacturing MI_030]( "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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![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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![GettyImages-1070902452-planning-tracking-packaging-shipment]( "Winning The Race To FPI With Early Randomization And Trial Supply Management")
Learn why the ability to get investigational products to sites, and appropriately store them, is not a given – and this oversight can have serious consequences.
