In this article, Chief Editor Tom von Gunden considers the expanding range of addressable targets for inhalation drug and biologics delivery. He reports on innovations in oral and nasal inhalation technology that enhance approaches to traditional respiratory indications, as well enable delivery of inhaled therapies to systemic targets beyond the nose and lungs.
- Why Operational Readiness Is The Missing Piece In Biosimilar Adoption
- From Vial To Prefilled Syringe: Mastering The Development Transition
- Rethinking The Blueprint For Bone Regeneration: The Next Evolution In Orthobiologics
- Can We Cure Diabetes?
- Reassessing Nanoparticle Immunotoxicity: From Well-Established To Novel Approaches
- 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?
ON-DEMAND WEBINARS
A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.
Learn about new data on nanotechnology formulations for multiple dose forms and routes of delivery, including oral, long-acting injectables, inhalation, and ophthalmic.
Modular suites with built-in contamination control streamline sterile manufacturing—supporting complex products, faster timelines, greater flexibility, less disruption, and scalable fill‑finish.
A highly concentrated non-aqueous suspension of an IgG1 was developed using a patented platform. Review how the particle size of the mAb impacts the overall behavior of the drug product.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![iStock-842481112-child-medicine-tablet-capsule]( "Age-Appropriate Pediatric Formulation Development")
Age-Appropriate Pediatric Formulation DevelopmentThere is a significant variability in the pharmacokinetics of the same drug and dosage form between pediatric and adult populations, and the factors impacting drug bioavailability are different in children.
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![GettyImages-1330728771-microscope-lab]( "De-Risking Visible Particles Through Component Selection")
De-Risking Visible Particles Through Component SelectionExplore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.
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![GettyImages-501743090_nasal spray]( "Key Considerations When Choosing A Device For Dry Powder Nasal Delivery")
Key Considerations When Choosing A Device For Dry Powder Nasal DeliveryBuilding on previous discussions, here we discuss the benefits of nasal delivery and the challenges of developing dry powder formulations by focusing on key devices that can be used for delivering dry powder nasal dosage forms.
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![GettyImages-1284529278-syringe-pre-filled-PFS]( "Sterile Injectable Therapies: Revolutionizing Lifecycle Management")
Sterile Injectable Therapies: Revolutionizing Lifecycle ManagementThe right balance of technical understanding, logistics, regulatory guidelines, and knowledge about product stability and quality is crucial for capitalizing on the benefits of shifting delivery formats.
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![GettyImages-2086161977-blister-packaging-liquid-medical-medicine]( "The Future Of Pharma Packaging Trends, Technologies, And Patient-Centric Solutions")
The Future Of Pharma Packaging Trends, Technologies, And Patient-Centric SolutionsPharmaceutical packaging must evolve alongside drug development to ensure stability, safety, and regulatory adherence, utilizing innovative designs to improve therapeutic outcomes and patient accessibility.
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![Simplify the journey]( "Delivering Macromolecules: Challenges Associated With The Delivery Of Biologic Drugs")
Delivering Macromolecules: Challenges Associated With The Delivery Of Biologic DrugsDevelopers need to look beyond the formulation of a stable drug all the way to patient compliance. Numerous pitfalls exist along the journey to bring a biologic combination product to market. This integrated solutions program can help you simplify the journey.
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![GettyImages-136640925-vial-vaccine]( "Zero-Stress Low Volume Aseptic Filling For Solids And Liquids")
Zero-Stress Low Volume Aseptic Filling For Solids And LiquidsAseptic filling technology is of utmost importance. Explore in great detail an aseptic filling solution that has been specifically designed for laboratory and R&D applications in the pharmaceutical industry.
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![Ingredients effectiveness medicine GettyImages-624034228]( "Are Drugs Becoming More Lipophilic Over Time?")
Are Drugs Becoming More Lipophilic Over Time?Get a deeper look into how drug lipophilicity has evolved over time, its impact on drug development, and the need for new technology to enable new more complex drugs.
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![westextractables]( "Extractables And Leachables – Assessing Risk In A Complex Landscape")
Extractables And Leachables – Assessing Risk In A Complex LandscapeIt is not surprising that there is still confusion on the extractable and leachable topic. Guidances, where available, do not give step by step instructions on testing.
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![West]( "Design And Packaging Advantages For Cell And Gene Therapy Drugs")
Design And Packaging Advantages For Cell And Gene Therapy DrugsWith the increasing demand for cell and gene therapies, Crystal Zenith nested vials can help the biopharma industry overcome the challenges of scaling up manufacturing and logistics.
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]( "From Vial To Prefilled Syringe: Mastering The Development Transition")
From Vial To Prefilled Syringe: Mastering The Development TransitionIn this article, Fran DeGrazio discusses the opportunities, challenges, and benefits for biopharmaceutical product developers in transitioning from vial-based to prefilled syringe (PFS) delivery approaches. She lays out key differences and added complexities in areas such as device functionality, risk management, regulatory pathways, use of materials, lifecycle management, and organizational alignment.
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.
