CLINICAL SUPPLY MANUFACTURING ARTICLES
The Small Biotech's Checklist For FIH Trials
Getting medicine to its first patients is enormously complex with many players and moving parts. These are the critical steps.
CLINICAL SUPPLY MANUFACTURING VIDEOS
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.
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.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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![3_PharmaSource_Conference_CDMO Live copy]( "Vertex On Building Risk Into Manufacturing Network Strategy")
Supply disruptions are becoming harder to predict. Explore practical strategies for continuity planning, supplier risk management, and network design to build lasting resilience.
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![Microscope of cell, Embryonic stem cell]( "Optimizing Autologous Cell Therapy Clinical Trials")
Delve into four articles regarding dissecting the critical resources, processes, and key stakeholders essential for the successful completion of an ACT clinical trial.
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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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![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-1405217456 woman in lab]( "De-Risking Your Bioconjugate's Path To Clinical Manufacturing")
Explore the challenges when moving a bioconjugate candidate from early development to clinic, along with integrated solutions for navigating this growing area of the biopharmaceutical industry.
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![Laptop clinical trials iStock-653839742]( "What Are Decentralized Clinical Trials (DCTs)?")
Discover how DCTs leverage “virtual” tools, such as telemedicine, sensory-based technologies, wearable medical devices, and direct delivery of study drugs and materials to patients’ homes.
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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.
