Infusion Drug Delivery Articles

1. Qualification And Validation Of Depyrogenation Tunnels And Autoclaves 10/2/2026

   Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization. 

2. Engineering Better ADCs, Part 2: Characterization, CMC, And More 10/1/2026

   Let's take a closer look at antigen selection and tumor biology, PK and PD, analytical characterization, CMC, toxicity, and more.

3. Engineering Better ADCs, Part 1: MoA, Conjugation Chemistry, And More 9/24/2026

   The field has evolved considerably in antibody–drug conjugate (ADC) science. In this first article of a two-part series, let's discuss how to engineer better ADCs, covering MoA, conjugation chemistry, and more.

4. Beyond GalNAc: Reengineering siRNA For Extrahepatic Delivery 9/9/2026

   We discuss why effective extrahepatic delivery remains one of the field's biggest obstacles and how chemical engineering may provide a new path forward.

5. Engineering CAR T Cells With mRNA-LNPs: Applying Oncology Learnings To Allergic Diseases 9/4/2026

   Targeted lipid nanoparticles (LNPs) could deliver mRNA encoding a CAR directly to T cells inside a patient with allergic disease. The potential implications extend beyond a single allergic condition. 

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 Unpacking The FDA Draft Guidance On Container Closure Systems 8/26/2026

   In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems.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).

7. Why Delivery Is Defining The Next Era Of Neuromuscular Therapeutics 8/19/2026

   Emerging therapies are being designed to safely deliver oligonucleotides to disease-relevant tissues. Delivery is no longer a technical hurdle to overcome but a strategic lever.

8. Why Operational Readiness Is The Missing Piece In Biosimilar Adoption 8/3/2026

   Biosimilar success depends on seamless execution. Strong care coordination, patient education, and operational readiness are essential to improve access, adherence, and outcomes.

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. Red Blood Cell-Based Delivery: Promising Steps Forward 7/13/2026

    At Carnegie Mellon University, researchers have developed a new method for loading biologically active components into red blood cells. We discuss what this means for the future of drug delivery.