Articles, App Notes, Case Studies, & White Papers

  1. An Elegant Solution For Delivery Of Acid Sensitive Pharmaceuticals 12/6/2022

    Sustained release drug delivery products offer effective therapies in the treatment of serious chronic diseases, and their development requires customized solutions with tunable material properties.

  2. The Challenges And Opportunities Of Real-World Evidence: Part I 12/12/2024

    Explore how the FDA's Real-World Evidence framework helps integrate real-world data into drug approval, improving efficiency, while ensuring data reliability and regulatory compliance.

  3. 5 Ways Pre-Filled Syringes Contribute To Better Patient Outcomes 5/23/2025

    In our series on pre-filled syringes, we explore five key ways this delivery format is enhancing patient outcomes, not just through the medicine it contains, but through the device design itself.

  4. Leachables Method Development, Validation And Relevant ICH References 5/16/2025

    It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.

  5. Why 'Off-The-Shelf' Devices Do Not Circumvent Design Controls 9/20/2022

    Utilizing off-the-shelf (OTS) devices for drug delivery can offer significant advantages to development programs in timeline and risk mitigation. Understand the design control responsibilities of a sponsor when using OTS devices.

  6. Off-The-Shelf Vs. Novel Devices: Selecting A Drug Delivery System 4/19/2022

    Whether bringing a novel therapy to market or altering current devices, companies must determine the best selection for administration without impacting drug efficacy, quality, and safety.

  7. When Glass Vials Fail At Low Temps, Consider A Cyclic Olefin Polymer System

    If the glass vial for a biologic drug experiences breakage, or does not maintain container closure integrity, a cyclic olefin polymer (i.e., Daikyo Crystal Zenith COP) system may be the solution.

  8. Small-Scale Aseptic Filling Technology Considerations 2/23/2023

    Small-scale aseptic filling presents a unique set of challenges. Learn what to look for when evaluating small-scale aseptic filling technology.

  9. Formulation Development Strategy For Early Phase Human Studies 1/27/2022

    Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.

  10. How Nanoparticle Platforms Are Unlocking Genetic Medicine's Potential 4/1/2025

    Explore how the HIT SCAN platform accelerates gene therapy delivery by screening polymeric nanoparticles, enhancing precision and regulatory pathways for next-generation genetic medicines.