CLINICAL SUPPLY MANUFACTURING ARTICLES
3 Strategies For mAb Manufacturing: How Do You Choose?
As cost and supply come under more scrutiny, there are primarily three scaling strategies for mAb manufacturing that can be leveraged, each with its own set of pros and cons.
CLINICAL SUPPLY MANUFACTURING VIDEOS
Susan Dexter, Chief Technical Officer, Sonnet BioTherapeutics, describes the good choices she made, and one not-so-good choice, in trying to untie a knotted supply chain.
Early planning mitigates risk by avoiding stock outs and study delays, minimizing waste with optimized inventory, and forecasting demand to facilitate robust supply planning.
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-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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![West]( "Vial Containment Systems For Gene And Cell Therapies")
CZ vial-stopper-seal combinations offer a viable solution for the challenges associated with low-temperature storage of cell therapy drug products.
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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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![GettyImages-155372946-cold-chain-cryopreservation-logistics]( "Optimizing Cell Therapy Supply Chains For Success")
When it comes to transporting highly sensitive and valuable materials, such as cell therapies, learn how teams can ensure that unique storage and distribution requirements are met.
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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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![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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![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.
