CLINICAL SUPPLY MANUFACTURING ARTICLES
The Hidden Cost Of Convenience: Single-Use Supply Chain Vulnerabilities And Clinical Trial Continuity
Single-use technologies improve flexibility, but overreliance on single suppliers can jeopardize trial continuity. Learn how to build resilience before disruptions occur.
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.
This session presents a risk-based framework for high-potency micronisation, illustrated through a practical case study that spans development to commercial scale.
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.
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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![West_GCApp_MG (person picking up container)]( "Understanding Injectable Drug Container Closure Systems")
Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.
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![GettyImages-155372946-cold-chain-cryopreservation-logistics]( "Cold Chain Services For Clinical Trial Success")
As innovative, complex therapeutics advance toward clinical trials, properly handling, storing, and packaging temperature-sensitive critical materials is essential to maintain product integrity.
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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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![GettyImages-1298788278 drug manufacturing]( "GxP Inventory Solution Improves Clinical IP Efficiency And Compliance")
Learn how this biopharmaceutical research sponsor was able to centralize and digitalize the processes involved in clinical supply production through distribution using GxP Inventory.
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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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![clinical-trial-study-design-GettyImages-2215843204]( "Microdosing Technology: Accelerating Clinical Development From Phase 1 To Market")
Capsule-based microdosing of low-dose API is moving beyond early-phase trials. Precise filling at 1 to 200 mg raises questions about formulation continuity, scale-up, and time to market.
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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.
