CLINICAL SUPPLY MANUFACTURING ARTICLES
New DSCSA Compliance Blueprint Includes FDA & Industry Input
Pharmaceutical manufacturers, distributors, and pharmacies must all ensure they are ready for the Drug Supply Chain Security Act (DSCSA)'s full implementation starting on Nov. 27, 2023. The Partnership for DSCSA Governance, a public-private partnership, has published a blueprint compiling input from every sector, including FDA, industry, and solution providers.
CLINICAL SUPPLY MANUFACTURING VIDEOS
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.
Early planning mitigates risk by avoiding stock outs and study delays, minimizing waste with optimized inventory, and forecasting demand to facilitate robust supply planning.
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.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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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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![Singota-DSC03221]( "Developmental Testing Of IV Solutions")
As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.
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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-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.
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![Scientist syringe vaccine GettyImages-1351831059]( "Overcome The Supply Chain Complexities Of Vaccine Development")
Explore the industry impact of rapidly evolving vaccinology, the power of next-gen science and technology, and how finding the right supply chain partner has never been more essential.
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![Vaccine injectable vials and syringe GettyImages-1252804942]( "Packaging And Containment: Get Your Products To Market Faster")
Learn more about why focusing on packaging solutions early on can keep development on track, help you meet milestones, and get your product to market faster.
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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.
