Featured Editorial

  1. Oral Therapies Take Center Stage For PsO And PsA Treatment 4/1/2025

    The recent American Academy of Dermatology 2025 Annual Meeting in early March saw major updates for two key oral therapies in autoimmune diseases.

  2. Design Controls For Drug Delivery Devices, Part 1: A Process Primer 4/1/2025

    In this article, Fran DeGrazio underscores the importance of design controls in the development of combination products and other drug delivery devices. She explains foundational concepts and fundamental steps including design inputs and outputs, design verification and validation, design review, and change controls. 

  3. The Importance Of Primary And Secondary Drying And Their Impact On Lyophilization 3/25/2025

    For parenteral formulations, biologics, and vaccines, the lyophilization process's primary and secondary drying stages require precise control of temperature, vacuum, and duration. 

  4. 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.

  5. 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?

  6. Combination Products: US And EU Requirements And Harmonization 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.