Next-generation orthobiologics could transform spinal fusion by enabling targeted bone regeneration, improving safety, and reducing reliance on traditional grafts and hardware.
- Delivery Device Functional Scrutiny: Can You Pass (Without) The Test?
- Red Blood Cell-Based Delivery: Promising Steps Forward
- Stability And Release Testing For Delivery Devices: Waived Or Wanted?
- Microneedles In Drug Delivery: From Bench To Patch
- How Targeted Nanoparticles And Circular RNA Are Advancing CAR-T Development
- Beyond The Surface: Balancing Efficacy, Safety, And Patient Experience In Ophthalmic Delivery
- Enhancing Gene And Cell Therapies With Circular RNA-Based Gene Expression
- Biomaterials In Ophthalmology Are Reshaping Ocular Drug Delivery
ON-DEMAND WEBINARS
Using a comprehensive approach to component selection mitigates risks to fill-finish and lyo processing. Explore key considerations for selecting lyophilization stoppers suitable for intended use.
Discover a screening process to quickly assess HME feasibility that yields more accurate predictions for API loading and degradation while saving material and time compared to traditional approaches.
Explore regulatory framework and expectations, and see the benefit of a comprehensive approach to CCI tailored for mAbs and complex modalities such as fusion proteins or bioconjugates.
Learn how advanced containment solutions support high-viscosity biologics, improve device compatibility, enhance injection performance, and address evolving drug delivery and patient care challenges.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1310024666-genetic-digital-dna]( "How Nanoparticle Platforms Are Unlocking Genetic Medicine's Potential")
How Nanoparticle Platforms Are Unlocking Genetic Medicine's PotentialExplore how the HIT SCAN platform accelerates gene therapy delivery by screening polymeric nanoparticles, enhancing precision and regulatory pathways for next-generation genetic medicines.
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![GettyImages-597935610 cell and gene]( "Delivering The Promise Of Gene Therapy")
Delivering The Promise Of Gene TherapyGene therapies rely on efficient, precise methods of delivering genetic material. Examine how combining polymeric nanoparticles with CRISPR therapies is increasing the potential for improved treatment.
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![GettyImages-1284529278-syringe-pre-filled-PFS]( "New Perspectives On Accelerating Genetic Nanomedicines Through The Regulatory Pathway")
New Perspectives On Accelerating Genetic Nanomedicines Through The Regulatory PathwayDiscover how regulatory bodies are adopting a risk-based approach to address the unique challenges of genetic nanomedicines, and stakeholder engagement is essential.
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![Regulatory]( "The Challenges And Opportunities Of Real-World Evidence")
The Challenges And Opportunities Of Real-World EvidenceThe FDA's Real-World Evidence framework addresses challenges in using Real-World Data for regulatory decisions, emphasizing data reliability, bias management, and successful case studies.
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![GettyImages-1279969622-self-injector-injection]( "Streamlining The Path To Market For Generic Drug-Device Combinations")
Streamlining The Path To Market For Generic Drug-Device CombinationsDeveloping g-DDCPs is a complex and time-consuming process. By using a risk-based approach, manufacturers can streamline the development process and bring g-DDCPs to market more quickly.
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![West-vials]( "Low Temperature Storage Containment For Vial And Syringe Systems")
Low Temperature Storage Containment For Vial And Syringe SystemsWith the growth of advanced therapy medicinal products, there is an increased need for specialized low-temperature packaging solutions, particularly for vials and syringe systems at -50°C to ≤ -130°C.
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![West Pharma - Article 1 - 4040-40 Lyotec 13mm 20mm Group V2]( "Vial Containment Systems Based On Elastomer 4031/45 Gray")
Vial Containment Systems Based On Elastomer 4031/45 GrayExamine the results of two, two-year studies that indicate good container closure integrity performance that can be achieved with stoppers of a given elastomer, independent of configuration.
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![GENiSYS-R-full-machine]( "Utilizing Robotic Aseptic Filling Systems To Meet Industry Needs")
Utilizing Robotic Aseptic Filling Systems To Meet Industry NeedsAn aseptic filling and closing machine solution allowed Catalent to reliably process a wide range of both trayed and nested vials for their client product needs.
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![GettyImages-471887979-pediatric-kids-eye-exam]( "Formulation Considerations For Pediatric Populations")
Formulation Considerations For Pediatric PopulationsBy partnering with a CDMO with experience in pediatric formulation, pharmaceutical companies can increase acceptability of their drugs among pediatric patients.
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![West]( "Vial Containment Systems For Gene And Cell Therapies")
Vial Containment Systems For Gene And Cell TherapiesCZ vial-stopper-seal combinations offer a viable solution for the challenges associated with low-temperature storage of cell therapy drug products.
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.
