Injectable Drug Delivery Articles

  1. From IV To Subcutaneous: It's Not About Convenience, It's About System Design 4/6/2026

    IV→SC transition extends beyond dose, volume, concentration, and device; it requires integrated system design, not a series of isolated optimizations.

  2. 6 Packaging And Delivery Challenges For Biologic Therapies 4/1/2026

    In 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. 

  3. Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables 3/17/2026

    A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.

  4. Closing The Adherence Gap: The Connected Health Era 3/13/2026

    Connected health is shifting healthcare from reactive to proactive by enabling providers to oversee drug delivery while allowing patients to actively engage in their care.

  5. Delivery Strategy For Next-Gen Cardiac Gene Therapies 3/12/2026

    As the field matures, the most transformative gene therapies in heart health are treating delivery not as an afterthought but as a fundamental principle.

  6. Injecting Cancer Killers: Intratumoral Therapy For Solid Tumors 3/5/2026

    Intratumoral injection bypasses the tumor’s physical defenses entirely, killing cancer cells and creating a personalized immune response that destroys solid tumors.

  7. GenAI: The Muscle Behind Strong Regulatory Intelligence For Combination Products 3/2/2026

    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. 

  8. Regulatory Precedents For Drug Delivery: Uncovering Clues To Successful Submissions 3/2/2026

    In this article, Chief Editor Tom von Gunden considers the need for and benefit of conducting AI-based research into regulatory precedents for drug delivery submissions and approvals. He consults combination products consultant Doug Mead on best practices in bolstering regulatory intelligence and regulatory approval success by way of advanced search methods. 

  9. RNA Delivery Technologies: Industrial Applications And Emerging Innovations 2/10/2026

    RNA delivery is moving from breakthrough to backbone. This review examines how LNPs and emerging carriers are reshaping scalability, targeting, manufacturing, and real-world deployment of RNA therapeutics.

  10. 4 Opportunities For Advancing Drug Delivery 2/3/2026

    In this article, Fran DeGrazio identifies four prime opportunities for drug delivery developers to move the dial of innovation into 2026 and beyond. These avenues for advancement include diagnostics, patient tolerability, microdosing, and analytical methodologies.