DELIVERED BY DEGRAZIO

• Unpacking The FDA Draft Guidance On Container Closure Systems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  In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems.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

• 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.

• Procuring Packaging And Delivery Systems: Single Versus Dual Sourcing

  6/2/2026

  In this article, Fran DeGrazio examines the trend toward dual sourcing of products, components, and materials for drug delivery packaging and systems. She outlines the key differences between single and dual sourcing and makes recommendations about using one versus the other while mitigating supply chain and product quality risk. 

• 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. 

• 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. 

• Drug Delivery Trends From 2025: Top 4 For Momentum Gains In 2026

  12/2/2025

  In this article, Fran DeGrazio identifies four notable trends in drug delivery that gained momentum in 2025 and, she predicts, will continue to do so in 2026 and beyond. They are digitalization, sustainability, patient centricity, and the advanced delivery of complex biopharmaceuticals.

• Drug Delivery Innovation: Getting Advanced Therapies To Patients

  11/3/2025

  In this article, Fran DeGrazio recounts the evolution of drug delivery technologies as she underscores the need to innovate in the delivery of advanced therapies. Considering chronic diseases, rare diseases, and difficult-to-reach therapeutic targets, Fran offers suggestions for organizing and readying for the development and delivery of platforms, systems, and devices for next generation treatments, including personalized, precision medicines.

• Drug Delivery Product Strategy: Aligning The Organization For Execution

  10/1/2025

  In this article, Fran DeGrazio offers recommendations to biopharmaceutical sponsor companies about best practices for aligning strategic product initiatives with functional area execution. She outlines 5 key considerations, illustrated with the increasingly common market strategy expansion from drug product development to drug-device combination product delivery.

• 7 Management Strategies For Combination Product Regulatory Success

  9/2/2025

  In this article, Fran DeGrazio lays out best practices for biopharma executive leadership and non-technical managers to sustain regulatory momentum for their combination product development and commercialization. Fran points to cross-functional collaboration, quality management systems, regulatory documentation, and post-market surveillance as keys to drug delivery product success. 

• Understanding Annex 1 For Sterile Medicinal Products

  8/4/2025

  In this article, Fran DeGrazio outlines concepts from the EU Annex 1 guidance for sterile medicinal products. She highlights key considerations for the manufacturing of sterile products and offers recommendations for contamination control, facilities upgrades, quality risk management, testing, inspections, and personnel training.