In this article, Chief Editor Tom von Gunden discusses the alignment of drug delivery method with patient preference and need. He reflects on recent conversations in which he heard from experts in drug and delivery product development, as well as patients themselves, about patient-centric considerations such as safety, efficacy, usability, and convenience. The primary use case is the transition from clinically administered IV to subcutaneous injection, including self-administration.
- Reformulating An In-Clinic IV To At-Home Injection Puts Patients At The Center
- AI, Digitalization, And In Vivo Programming Redefine Cell And Gene Therapy
- Minding The Gap: Submission Strategies For Combined Use Combination Products
- Advances In Precision Delivery In CNS Oncology
- Drug-Device Combination Products: 4 Evolving Platforms For 2026
- A Case Study: Control Strategies For A Multi-Dose Pen Injector
- Control Strategies For Injectable Drug Delivery Combination Products
- From IV To Subcutaneous: It's Not About Convenience, It's About System Design
ON-DEMAND WEBINARS
Watch to hear Steven Facer, Adare's Vice President of Business Development EU/ROW, discuss the challenges of pediatric oral solid dose manufacturing and how to overcome them.
Spray drying offers a solution to formulation challenges for enhancing the bioavailability of poorly soluble APIs but requires technical capability and operational excellence to accomplish the process successfully.
Taste masking for children can present unique challenges for drug developers. Learn how we can use flavor, not just to provide a desired taste, but also to provide taste masking.
Gain valuable insights into the jet milling process and Quality by Design approach for inhalation drug delivery and their potential applications in drug development.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![US-EU-flag-3D-GettyImages-94920629]( "Effects Of Annex 1 Revisions On Manufacturing Operations")
Effects Of Annex 1 Revisions On Manufacturing OperationsThe revisions to EU Annex 1 set the stage for the future direction of the pharma/biotech industry. Explore some of the key takeaways and interesting changes for risk management and contamination control strategies.
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![GettyImages-525440891-lab-research-development]( "Avoiding The Pitfalls Of LNPs And Complex Formulations")
Avoiding The Pitfalls Of LNPs And Complex FormulationsExplore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.
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![GettyImages-872019514-dna-gene-teach]( "Container Closure Integrity Evaluation For Cell And Gene Therapies")
Container Closure Integrity Evaluation For Cell And Gene TherapiesWith the growth of gene and cell therapies, there is an increased need to characterize container closure systems at the low temperatures experienced during their lifecycles.
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![iStock-843765314-scientist-lab]( "Solutions For Accelerated Pharmaceutical Development")
Solutions For Accelerated Pharmaceutical DevelopmentExplore an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties such as low aqueous solubility and poor bioavailability.
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![adare osd]( "Combining Powdose® And Diffucaps® For Precise Solid Oral Dosing")
Combining Powdose® And Diffucaps® For Precise Solid Oral DosingCombining POWDOSE® and Diffucaps® enables precise, individualized solid oral dosing—improving drug delivery, patient compliance, and therapeutic outcomes in personalized medicine applications.
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![GettyImages-2161651129_elderly pharmacy]( "A Taste Masked And Easily Swallowed Malaria Drug For Elderly Patients")
A Taste Masked And Easily Swallowed Malaria Drug For Elderly PatientsDysphagia impacts treatment compliance and disproportionately affects the elderly. Learn how microencapsulation enabled formulation of a water-soluble powder drives patient adherence.
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![West]( "USP <382>: Think Systems, Not Components")
USP <382>: Think Systems, Not ComponentsThis blog focuses on the application of USP <382> prescribed testing to cartridges and syringes from a mechanical testing perspective.
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![02 West]( "Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics")
Essential Drug Delivery Outputs For Devices To Deliver Drugs, BiologicsAll future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.
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![image2]( "How To Address Challenges In Oncology Drug Containment")
How To Address Challenges In Oncology Drug ContainmentDrug product containment systems comprising Daikyo Crystal Zenith® cyclic olefin polymer (COP) vials, matched with NovaPure® stoppers, offer container closure integrity (CCI) performance that has been quantified for oxygen and carbon dioxide, and they have excellent system performance.
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![GettyImages-1346675635-lab-tablet-research-team]( "Simultaneous Spray Drying For Innovative Dry Powder Inhaler Combination Formulations")
Simultaneous Spray Drying For Innovative Dry Powder Inhaler Combination FormulationsDr. Kimberly Shepard, a principal R&D engineer at Lonza, offered insights on recent innovations pioneered in spray drying. Shepard also discussed spray drying technologies capable of combining small-molecule APIs with biotherapeutic molecules.
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]( "6 Packaging And Delivery Challenges For Biologic Therapies")
6 Packaging And Delivery Challenges For Biologic TherapiesIn this article, Fran DeGrazio identifies six aspects of biologics-based therapy packaging and delivery that, if addressed, may help to ensure successful product development and lifecycle management. They include 1) chemical compatibility with device functionality, 2) long-acting formulations, 3) product stability, 4) primary packaging and device integration, 5) cold storage, and 6) higher concentrations and viscosities.
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.
