Featured Editorial

  1. The Technologies Propelling GLP-1 Analogues 3/18/2025

    This article delves into the manufacturing and synthesizing technologies used to manufacture GLP-1 drugs as well as the novel drug delivery technologies being used.

  2. Are CDMO Partnerships The Answer To Manufacturing Capacity Issues? 3/13/2025

    The current manufacturing strain is exacerbated by factors such as the intensity of scaling up fill-finish and specialized manufacture of drug delivery devices. How can partnering with a CDMO help?

  3. Combination Products: U.S. Vs. EU Requirements And A Harmonized Strategy To Prepare CTD Module 3 3/6/2025

    In the U.S. and the EU, there are differences in the terminology used for combination products, as well as in the format and location of the information in the dossiers. This article also proposes a harmonized approach for CTD Module 3.

  4. Addressing Challenges In Automated Visual Inspection Of Lyophilized Vials 3/4/2025

    Manual inspection is inefficient. Automated systems can struggle with the variability of lyo cake structures. Key technological advancements are coming to the forefront to address these issues.

  5. Subcutaneous Self-Administration: 3 Key Market Drivers, 3 Key Delivery Challenges 3/4/2025

    In this article, Fran DeGrazio comments on the potential for subcutaneous delivery of drugs and biologics to advance and ease approaches to patient self-administration. Among the drivers and challenges she identifies are geriatric populations, chronic conditions, complex formulations, and drug delivery device selection.

  6. Growth And Advancements In Transdermal Drug Delivery 2/19/2025

    The transdermal drug delivery system industry is seeing significant growth. Let's look at new market research, including the advanced technologies being used and the therapeutic areas seeing the most impact.

  7. Comparison Of WFI Production Methods: Multi-Effect Distillation Vs. Vapor Compression 2/18/2025

    The two most common hot water for injection (WFI) generation methods are multi-effect distillation (MED) and vapor compression (VC). There are significant differences in terms of operational principles and energy efficiency.

  8. How Automation And AI Can Accelerate Clinical Research And Outbreak Response 2/18/2025

    Explore AI-driven automation and organ-on-a-chip technology to accelerate infectious disease research, enhancing assay efficiency, and improving vaccine and therapeutic development for emerging global health threats.

  9. PMS And Supply Chain Visibility For EU Compliance 2/10/2025

    One area that medical device manufacturers often overlook in post-market surveillance (PMS) planning for EU MDR and EU IVDR compliance is the role of the supply chain.

  10. Use-Related Risk Analysis: Considering The FDA Guidance On URRA 2/5/2025

    The FDA draft guidance on Use-Related Risk Analysis (URRA) announced in July 2024 helpfully clarified key considerations regarding the identification and mitigation of potential hazards in biopharmaceutical product use. In this article, Fran DeGrazio comments on the guidance in a follow-up to a Drug Delivery Live! online event she moderated on the topic of URRA.