CLINICAL SUPPLY MANUFACTURING ARTICLES
Making Cancer Vaccines Is Complex; New Platform Guidance Could Help
FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.
CLINICAL SUPPLY MANUFACTURING VIDEOS
Expert speakers discuss current operational obstacles and explore strategic solutions to optimize a supply chain strategy in the years ahead.
Tony Sampognaro, Director, CMC Project Management, Stoke Therapeutics, recalls a rather harrowing experience involving a CMO and Clinical Operations failure to communicate.
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
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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![pharma-manufacturing- GettyImages-2274021643]( "Advance Your Program With Specialized CDMO Solutions")
Integrated drug development streamlines manufacturing, analytics, and supply to cut risk and speed timelines. Inhalation advances and flexible partnerships help therapies reach commercialization faster.
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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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![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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![small-mole-cdmo-GettyImages-1465073057]( "Breaking Down Early Small Molecule Development")
Adopt an integrated development strategy to streamline the path from early development to the clinic, ensuring timely clinical supply while reducing delays, risk, and inefficiencies.
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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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![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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![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.
