CLINICAL SUPPLY MANUFACTURING ARTICLES
What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma?
Deciding what is good enough to get started can support the mindset of building something without sacrificing quality, functionality, or safety.
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.
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.
Tony Sampognaro, Director, CMC Project Management, Stoke Therapeutics, recalls a rather harrowing experience involving a CMO and Clinical Operations failure to communicate.
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-184945838-cold-chain-cryopreservation]( "Prepping For Commercialization Through Supply Chain Logistics")
While cell and gene therapies are bringing new hope to patients experiencing rare and serious diseases, uncover how they're disrupting the biopharma market in new and challenging ways.
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![DD 3 - PFS Grouping 002]( "Lifecycle Planning For Containment And Delivery Of Biologics Drug Products")
Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development.
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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-184945838-cold-chain-cryopreservation]( "Building A Global Cell And Gene Supply Chain Serving Personalized Medicine")
Clinical distribution paths can be fragile for a multitude of reasons, making it critical that pharmaceutical sponsors and their partners orchestrate supply chain logistics even before site initiation.
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![cdmo-drug-assembly-manual-GettyImages-1339603591]( "Practical Playbook For The Manual Assembly Of Combination Products")
Manual assembly plays a vital role in early‑phase combination product development. Learn how strong process design, collaboration, and quality controls help teams reduce risk, improve consistency, and move confidently toward later‑stage manufacturing.
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![Panademic Related Manufacturing Complications]( "Outsourcers Are Feeling Uneasy About Continuity Of Supply")
Find out how COVID-19 complications have picked up from the first year, with more outsourcers experiencing bigger obstacles when it comes to manufacturing, specifically with drug product.
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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).
