INHALATION DRUG DELIVERY ARTICLES
GenAI: The Muscle Behind Strong Regulatory Intelligence For Combination Products
In this article, combination product consultant Doug Mead provides the rationale and offers guidance for using GenAI tools to search regulatory databases. He shows the benefits for biopharma developers of conducting “precedent research” into previous regulatory pathways and results for similar or related drug delivery product submissions.
INHALATION DRUG DELIVERY VIDEOS
In this segment of the Drug Delivery Leader Live online event, Next-Gen Drug Delivery: Rethinking Routes For New Therapies, Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, outlines key management considerations for biopharma companies developing combination therapies. These include suppliers, partnerships, quality, container closure, and regulatory.
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 4 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems with the book’s editor, Susan Neadle, and chapter co-author Mike Wallenstein. In the exchange, Susan and Mike share their perspectives on combination product CGMP’s, including regulatory definitions and differences in the U.S. and Europe, supplier controls, design controls, and manufacturer responsibilities.
How are EDDOs (Essential Drug Delivery Outputs) related to CGMPs (Current Good Manufacturing Practices) during the design of a drug-led or biologic-led combination product? In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC establishes the connection between the two regulatory concepts.
When and how might using a uFMEA (Use Failure Mode Effects Analysis) tool benefit biopharma companies addressing regulatory expectations for analyses of risk and/or human factors? In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Natalie, Abts, head of human factors engineering at Genentech, and Shannon Hoste, chief scientific officer at Pathway for Patient Health, discuss potential differences in the contexts, purposes, and degrees of detail in information presented for review.
INHALATION DRUG DELIVERY RESOURCES
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![GettyImages-952793068-inhalation-nasal spray]( "Examining The Emergence Of Unit- And Bi-Dose Nasal Sprays")
Nasal spray administration of medicine offers advantages over oral and IV delivery. Experts discuss the advantages and opportunities of adopting unit- and bi-dose nasal delivery technology.
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![Nasal Spray GettyImages-994129536]( "Key Considerations For Dry Powder Inhalation")
A focus on spray-drying expertise in pulmonary and nasal powder development highlights why it is vital to choose the right CDMO.
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![iStock-474771466-inhaler-inhale]( "Understanding The In-Vitro/In-Vivo Relationship (IVIVR): Inhaled Medicinal Products")
IVIVR modeling leverages in-vitro testing knowledge toward predicting in-vivo testing results, often reducing long-term development costs by facilitating more informed decision-making during drug development.
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![GettyImages-1182324431-Powder_Inhaler]( "Spray Drying To Enable New Inhaled Drug Products")
The formulation and spray drying process can help manufacture a stable, highly respirable powder and deliver products that require a high drug load, a biologic, or rapid onset therapeutic.
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![GettyImages-1302380490-Vaccine Nasal Spray]( "Nasal Vaccine Development, Manufacturing, And Device Selection")
When developing a nasal delivery program, a partner with experience in development and manufacturing techniques who can see a program through small-scale clinical to commercial supply is crucial.
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![GettyImages-1321279050-inhaler-inhalation-breathe-lungs]( "Six Inhaler Sustainability Myths – And Why They Must Be Busted")
The solution to the carbon footprint of respiratory disease is complicated. The prevailing “myths” must be examined and addressed to achieve the shared industry vision of a decarbonized inhaler market.
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In a recent webinar, Lonza discussed the process it uses to develop a spray dried powder formulation and scale from early feasibility studies to manufacturing.
INHALATION DRUG DELIVERY SOLUTIONS
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![GettyImages-1268574717-food-inspect-ship-package]( "A/L/P Assembly, Label And Packaging")
Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.
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![inhaler-GettyImages-2233485493]( "Pulmonary Drug Delivery")
Modern inhalation platforms, improved formulations, and greener propellants speed development and strengthen respiratory performance, with key factors guiding device choice and clinical readiness.
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![lung-health-GettyImages-1360866086]( "Fast-Tracking Healthier Tomorrows For Patients And Our Planet")
A focused look at how low‑GWP propellant technologies support sustainability goals while preserving inhaler performance, offering guidance for planning regulatory readiness, device compatibility, and long‑term respiratory portfolio strategy.
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![pulmonary-GettyImages-2148494976]( "Pulmonary")
See key inhalation platforms and their advantages, showing how targeted delivery, formulation flexibility, and patient-friendly design support efficient development and stronger therapeutic outcomes.
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![GettyImages-1600719545 lab]( "Innovative Formulations And Higher Drug Loads Across The Life-Cycle")
Advanced particle engineering enhances the performance and life-cycle of therapeutics. Superior bioavailability, higher drug load, and improved stability are enabled for small and large molecules.
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![analytical-timelines-GettyImages-2247278213]( "A Comprehensive Approach That's Exceptional By Design")
An overview of analytical capabilities to boost product quality, meet regulatory expectations, and drive development through phase‑appropriate methods and specialized testing for complex drug programs.
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![GettyImages-871317164-inhalation-inhaler]( "Designed For Inhalation: Pulmonary And Nasal Delivery")
Our newly expanded in-house capabilities span clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays.
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![GettyImages-1435081495-Self-Injector_Auto-Injector]( "Transforming Drug Delivery")
Learn how our team of scientists, engineers, and human-centered designers, as well as our world-class facilities, empower us to confidently guide your product toward a successful market launch.
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![iStock-493302504-scientist-lab-development]( "Pre-Formulation And Material Sciences")
Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.
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![Working on testing machine]( "Organ On A Chip: Advancing New Approach Methodologies")
Explore new approach methodologies, integrating in vitro and computational models to improve toxicology testing, and drug development, enhancing accuracy, efficiency, and human relevance.
