CLINICAL SUPPLY MANUFACTURING ARTICLES
Challenges And Opportunities Of Outsourcing Biopharma Development
Oversight, knowledge management, and operational/compliance risk make up the three key challenge classifications to consider when approaching a new outsourcing agreement.
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.
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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![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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![iStock-1293772969-lab-microscope-scientist-research]( "Clinical Manufacturing: What It Is And How It Works")
Clinical manufacturing is a specialized form of pharmaceutical manufacturing focused on producing drugs for clinical research. How does it work and how is it different from commercial 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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![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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![GettyImages-836663414 medical team meeting]( "Sponsor Overcomes Hold And Steers Products Through Development")
Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.
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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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![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.
