Infusion Drug Delivery Articles

1. Nanosystems And Rare Diseases: Opportunities And Limitations 3/27/2026

   Nanosystems offer unique capabilities, enabling researchers to design precise, versatile delivery systems that address key challenges in rare diseases.

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   A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk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

3. The Future Of Kidney Disease Therapeutics: Bringing Nanomedicine To Nephrology 3/6/2026

   Nanomedicines are solving the drug delivery problem in kidney disease. The next step: bridging the translational gap to advance these technologies into the clinic.

4. The Advantages Of Antibodies Over Ligands In The Alpha Emitter Era 3/5/2026

   The alpha era in radiopharmaceuticals is still being defined. The choices developers make now about delivery platforms will shape individual programs and the trajectory of the field.

5. 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. 

6. 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. 

7. Benchmarking RNA Delivery Performance: Toward Standardized Metrics For Translational Success 2/24/2026

   As RNA pipelines mature, delivery success demands shared benchmarks. This article proposes standardized, stage-specific metrics to compare platforms, guide optimization, and strengthen regulatory confidence.

8. Advances In Endometrial-Targeted Drug Delivery In Women's Health 2/19/2026

   Johns Hopkins investigators discuss gaps in women’s health research and how their work addresses endometrial dysfunction and infertility through precision nanomedicine.

9. 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. 

10. The Great Cell Therapy Reset: Solving The Industrial Math Of Living Drugs 1/15/2026

    The cell therapy sector is experiencing a paradigm shift in manufacturing: from bioreactor (ex vivo) to body (in vivo).