Software-enabled combination products demand early cross-functional alignment, regulatory foresight, and collaboration to avoid delays and accelerate patient access.
- From Exosomes To Nanodrugs: Advancing Therapeutic Delivery For CNS Repair
- Risk Is the Spine: What The First 100 QMSR Inspections Reveal
- Advancing Autologous Stem Cell Engineering For Diabetes And Vision Loss
- The Hidden Operational Complexities Of Home Infusion
- Spine Care Redefined: Autologous Cell Therapy For Degenerative Disc Disease
- Surgical Therapeutic Design: Key Considerations In Formulation And Delivery
- Need A Drug Delivery Conversation Starter? Try Target Product Profile
- When Software Becomes Part Of The Medicine
ON-DEMAND WEBINARS
We showcase the development of high drug load nanocrystal based tablets and prove that nanocrystals can match the pharmacokinetic performance of ASDs while reducing the overall pill burden.
Explore the latest in nanotechnology advancements including recent clinical data, formulation applications, and API optimization to NanoImprove formulations.
Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.
‘Brick dust’ compounds require additional steps if spray drying is to yield a commercially attractive process. Explore three enabling technologies designed to improve drug solubility in organic solvents for spray drying.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![West Pharma - Article 2 - ELAS LYO Lyotec-012 LREZ]( "Have You Selected The Right Stopper For Your Lyophilized Drug Product?")
Have You Selected The Right Stopper For Your Lyophilized Drug Product?Component selection is a complex process. Packaging considerations should occur concurrent with drug development to mitigate risk at every step of the drug development process.
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![GettyImages-1694119644-Insulin_Injector_Pen]( "Delivering On GLP-1 Demand: Combining Device And Supply Strategy")
Delivering On GLP-1 Demand: Combining Device And Supply StrategyMeeting the demand for GLP-1 treatments requires robust and efficient delivery systems. Review how innovative solutions offer customization, streamlined manufacturing, and formulation compatibility.
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![GettyImages-1185624320-scientist-lab-smiling]( "Selecting A CDMO For Custom Activated PEGs")
Selecting A CDMO For Custom Activated PEGsCustom-activated PEGs require thoughtful planning and precise analytical control. Discover key considerations for selecting a partner capable of supporting scalable, compliant PEGylation.
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![GettyImages-1294339649 drug development, cleanroom]( "How DFM Promotes Scalability, Repeatability, And Profitability")
How DFM Promotes Scalability, Repeatability, And ProfitabilityFind out why it is critical that OEMs see and understand the benefits of taking time to build a mold or create automation more robustly to achieve long-term savings and higher annual production.
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![Getty Images-823447656-vector-viral-lab-AAV-cell-development]( "Snapshot Of The Parenteral Drug Delivery Market")
Snapshot Of The Parenteral Drug Delivery MarketGrowth in the development of parenteral drugs is driving demand for advanced drug delivery devices such as prefilled syringes, autoinjectors, and pen-injectors, growing segments in fill-finish manufacturing.
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![Enabling Long Lasting Clinical Outcomes In Coronary Stenting]( "Enabling Long Lasting Clinical Outcomes In Coronary Stenting")
Enabling Long Lasting Clinical Outcomes In Coronary StentingPolyester amides (PEAs) bring several desired and differentiating properties to drug-eluting stent (DES) applications for treating coronary artery disease (CAD).
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![DD 3 - PFS Grouping 002]( "Lifecycle Planning For Containment And Delivery Of Biologics Drug Products")
Lifecycle Planning For Containment And Delivery Of Biologics Drug ProductsRead 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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![GettyImages-1206035004-spectroscopy-lab]( "Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway")
Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) PathwayReview a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.
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![GettyImages-1335033345-cell-gene]( "How To Find The Right Balance In Cell Therapy Manufacturing")
How To Find The Right Balance In Cell Therapy ManufacturingThe choice between closed and open fill/finish for cell therapy drug products ultimately involves a careful balance between safety, accessibility, efficacy, and the type of cell type used.
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![iStock-1140779754-lab-team-research-equipment]( "Stability Chambers: Testing, Equipment, And Uses")
Stability Chambers: Testing, Equipment, And UsesPerforming stability studies is a critical step in the drug development process. Discover the ways to ensure that your drug is safe and effective as it goes to market.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
Fran offers keen industry and technical insights exclusively on Drug Delivery Leader.
DELIVERED BY DEGRAZIO
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![Delivered _by _DeGrazio_Logo_Color_2]( "Procuring Packaging And Delivery Systems: Single Versus Dual Sourcing")
Procuring Packaging And Delivery Systems: Single Versus Dual SourcingIn this article, Fran DeGrazio examines the trend toward dual sourcing of products, components, and materials for drug delivery packaging and systems. She outlines the key differences between single and dual sourcing and makes recommendations about using one versus the other while mitigating supply chain and product quality risk.
FREE EBOOK: COMBINATION PRODUCTS
Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
