Articles, App Notes, Case Studies, & White Papers

  1. Approach To Improve Solubility And Bioavailability: Spray Drying

    Spray dryers today support the development of some of the most advanced drug formulations, meeting the most precise morphological requirements to ensure performance, stability, and manufacturability.

  2. Advancements In GLP-1 Analog Formulation: Overcoming Challenges 2/3/2025

    Oral GLP-1 formulations represent a groundbreaking advance in obesity treatment to offer improved patient comfort and adherence while expanding the therapeutic market.

  3. Understanding Of Amorphous Solid Dispersions & Their Downstream Development 2/7/2022

    Understanding the properties of ASDs and their relationship to the downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs.

  4. Modern Modeling Tools For Small Molecule Solid Dose Manufacturing 3/10/2025

    Data-driven modeling techniques can enhance scale-up processes, streamline production, and help companies navigate the complexities of modern drug development with greater precision and reliability.

  5. The Importance Of A Human Centered Approach To Product Development

    To meet the needs of patients, life-saving device innovations are needed for the next generation of delivery devices. As drug manufacturers explore the device world, human factors are a key consideration.

  6. Accelerate LNP Manufacturing With Automated Process Development 2/5/2026

    Manual LNP formulation introduces process variability that threatens particle quality and yield. As programs scale toward clinical production, maintaining strict control over CQAs becomes essential.

  7. Is It Ever Too Soon To Start Your Performance Testing Assessment?

    Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.

  8. Driving Sustainability In Spray Drying Through Enabling Technologies

    By transitioning to alternative solvents or leveraging process aids, the challenges associated with the use of these chemicals can be addressed, helping create a sustainable, greener footprint.

  9. Accelerate Development Of Enabled Formulations For Poorly Soluble Drugs 8/21/2023

    Explore how a platform integrating drug substance, drug product, and clinical testing within a single organization accelerates development and reduces costs, helping deliver positive outcomes earlier.

  10. 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.