In this follow-up article, Chief Editor Tom von Gunden extends his Part 1 discussion of therapeutic targets for inhaled drugs and biologics into specific aspects of delivery innovation. Among the key considerations are particle engineering, device usability, and the coordination across the ecosystem of inhalation delivery design, development, and distribution. The coverage of advances in device technologies includes inhalers, nebulizers, and nasal sprays.
- Designing Nanoparticles: Why Size Comes First
- 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
ON-DEMAND WEBINARS
Explore 3D screen printing’s potential to revolutionize pharmaceutical manufacturing with scalable, customizable, multi-drug tablets and precise, patient-centric drug release profiles.
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.
Strengthen risk mitigation strategies while ensuring regulatory alignment. Gain valuable insights into best practices and proactive approaches for building a robust and future-ready CCS.
Launching a large molecule in one format and then switching the delivery format often transpires as a lifecycle management strategy for cost efficiency, supply chain continuity, and patient benefit.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Pharmaceutical-Drug-Manufacturing-GettyImages-1405788565]( "Nanoparticle Engineering Addresses The Challenge Of Poor Aqueous Solubility")
Nanoparticle Engineering Addresses The Challenge Of Poor Aqueous SolubilityAs pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.
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![GettyImages-1645853102-injectable-injection-self]( "Data-Driven Innovation Is Drug Delivery's Next Evolution")
Data-Driven Innovation Is Drug Delivery's Next EvolutionTo mitigate inherent risks like inconsistent dosing, user error, and low adoption due to complex usage procedures, technological innovation in delivery devices is best guided by lessons from the past, including user feedback and follow-on learnings from market data.
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![West1]( "Early Decisions To De-Risk The Transition To Combination Products")
Early Decisions To De-Risk The Transition To Combination ProductsThe injectable product development landscape is changing, and the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?
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![GettyImages-2036497686-lab-team-collaboration-laboratory-tablet-computer]( "Characterizing The E&L Profile Of Stoppers For Drug Stability")
Characterizing The E&L Profile Of Stoppers For Drug StabilityThe significance of E&L testing lies in its ability to identify potential risks associated with the use of containers and packaging materials in the pharmaceutical industry.
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![GettyImages-1346675538-lab-research-development-test tubes]( "Solubility With Lipid-Based Technologies For Oral & Injectable Formulations")
Solubility With Lipid-Based Technologies For Oral & Injectable FormulationsInnovative approaches in developing formulations can help to improve a drug's safety and efficacy. Explore the decision for selecting the best-suited technology for formulating a complex molecule.
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![GettyImages-995087800-lab]( "Drug Formulation Development: Quick Reference Guide")
Drug Formulation Development: Quick Reference GuideThis guide shares the steps involved in formulation development, considerations during formulation, and how partnering with an experienced CDMO can lead to a successful commercial product.
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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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![GettyImages-1481197683 water molecules]( "What is Hot Melt Extrusion, And How Can It Benefit Your Drug Product?")
What is Hot Melt Extrusion, And How Can It Benefit Your Drug Product?Poor API solubility delays pipelines. Discover how hot-melt extrusion creates amorphous solid dispersions to break down crystal lattices and boost bioavailability via solvent-free manufacturing.
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![iStock-474771466-inhaler-inhale]( "Understanding The In-Vitro/In-Vivo Relationship (IVIVR): Inhaled Medicinal Products")
Understanding The In-Vitro/In-Vivo Relationship (IVIVR): Inhaled Medicinal ProductsIVIVR 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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![point5mL_Syringe copy_WEST]( "The Clear Solution: Navigating Contamination Control For Ophthalmic Injectables")
The Clear Solution: Navigating Contamination Control For Ophthalmic InjectablesAs the intravitreal therapy market grows and applicable regulations evolve, continued compliance demands technological savvy and rigorous contamination control.
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.
