CLINICAL SUPPLY MANUFACTURING ARTICLES
Solving The Leukopak Supply Chain Issue With Cryopreservation
Allogeneic cell therapy developers report an alarming number of starting materials arrive at the wrong temperatures, late, or fail to arrive altogether.
CLINICAL SUPPLY MANUFACTURING VIDEOS
Expert speakers discuss current operational obstacles and explore strategic solutions to optimize a supply chain strategy in the years ahead.
Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.
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.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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![GettyImages-1467240751 patient doctor]( "Delivering Apheresis Treatment From The USA To The UK Within 24 Hours")
The goal was to perform next-day collection of temperature-sensitive tumor material for an urgent patient treatment. A flexible mitigation strategy was essential to manage short turnaround.
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![GettyImages-1254705026 clinical supplies]( "A Supply Chain Management Solution Designed for Clinical Research")
In this use case, follow along the clinical supplies management journey to learn how GxP Inventory replaces fragmented, spreadsheet-based processes to optimize visibility, traceability, and compliance.
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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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![pharma-success-GettyImages-2217587867]( "Why Advanced cGMP Manufacturing Is Key to Pharma Success")
Advanced cGMP facilities deliver control, expertise, and reliable processes that protect quality and support smooth progress to market. Strong partnerships help reduce risk in complex programs.
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![GettyImages-970394878-genetic-engineering-gene-editing-dna]( "Inside A Gene Therapy Facility, Commercialization & Industrialization Project")
An inside look at a clinical-stage company focused on bringing its gene therapy from the lab into a clinical setting for patients and families devastated by rare neurological genetic diseases.
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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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![GettyImages-1189150676-Medicinal_Marijuana_Cannabis_ControlledSubstance]( "Controlled Substances In Clinical Trials")
Handling controlled substances presents layers of complexity. Partnering with an experienced CDMO is essential for managing scheduled materials during clinical studies.
