Injectable Drug Delivery Articles

  1. The Future Of Cancer Drug Discovery Is Targeted Immune Activation 9/2/2026

    Using targeted delivery systems to generate therapeutic agents directly within tumors has implications for how oncology drugs are discovered and developed.

  2. Part 4 cGMP Summaries For Combination Products: Uncovering FDA Expectations 9/1/2026

    In this article, consultant Doug Mead reports on precedent research he conducted into FDA databases on 21 CFR Subpart cGMPs for combination products. His observations and conclusions offer sound advice on how to approach summaries submitted for BLA and NDA purposes. 

  3. Unpacking The FDA Draft Guidance On Container Closure Systems 8/26/2026

    In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems. She also addresses the integration of CCS guidance into the development organization’s QMS (Quality Management System).

  4. PLGA: A Workhorse Polymer Behind Modern Depot Long-Acting Injectables 8/7/2026

    PLGA-based long-acting injectables drive sustained drug delivery, with advances in generics, depot technologies, and manufacturing expanding patient access and innovation.

  5. Designing Nanoparticles: Why Size Comes First 8/4/2026

    Successful nanoparticle programs choose size intentionally, taking into consideration the physical, chemical, and biological consequences of size.

  6. From Vial To Prefilled Syringe: Mastering The Development Transition 8/3/2026

    In 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.

  7. Rethinking The Blueprint For Bone Regeneration: The Next Evolution In Orthobiologics 7/22/2026

    Next-generation orthobiologics could transform spinal fusion by enabling targeted bone regeneration, improving safety, and reducing reliance on traditional grafts and hardware.

  8. Can We Cure Diabetes? 7/15/2026

    We caught up with Minutia CEO Katy Digovich to discuss engineered iPSC-derived islets intended for transplantation into the forearm, which could make a functional cure for insulin-dependent diabetes broadly accessible.

  9. Reassessing Nanoparticle Immunotoxicity: From Well-Established To Novel Approaches 7/14/2026

    This article highlights government-funded resources available to de-risk nanomedicines, reviews principles of immunotoxicity testing, and discusses emerging methodologies.

  10. Delivery Device Functional Scrutiny: Can You Pass (Without) The Test? 7/13/2026

    In this article, Chief Editor Tom von Gunden considers the relationship between regulatory testing and the biopharma industry’s interest in leveraging drug delivery platform technologies to reduce regulatory burden in product development. Tom includes a conversation with guest columnist Doug Mead about waivers on testing in the context of FDA’s guidance on Essential Drug Delivery Outputs (EDDOs).