Articles, App Notes, Case Studies, & White Papers

  1. The Importance Of Strategic Alliance Partners In Biopharmaceuticals

    Today’s drug delivery systems are complex technologies that require close teamwork between biopharmaceutical companies and their drug delivery technology partners to develop innovative platforms.

  2. Compliance Considerations For Emergency-Use Delivery Systems 5/2/2022

    Because auto-injectors are typically the delivery device of choice for emergency medications, they come with increased scrutiny from regulatory bodies regarding their safety and effectiveness.

  3. Overcoming Melt Processing Challenges 7/21/2023

    Discover how a biodegradable polymer platform, easily applied with hot melt processing, enables processing at a relatively low temperature while preserving the potency of temperature-sensitive APIs.

  4. Understanding Injectable Drug Container Closure Systems 6/20/2024

    Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.

  5. The Gateway Delivery To The Brain 1/30/2026

    Nose‑to‑brain delivery enables targeted neurological treatment by using direct neural pathways to boost precision and limit systemic exposure, with new formulations and devices driving rapid progress.

  6. Steps To Overcome Challenges Associated With Biologic Formulation Development 8/24/2022

    Explore guidance on the challenges posed by biologics, including overcoming degradation, establishing a stress test process, and the value of lipid nanoparticles (LNPs) and polymeric nanoparticles (NPs).

  7. Considerations In Development & Manufacturing Of Complex Injectables For Early Phase Studies 2/7/2022

    A niche CDMO, with specialized technologies in complex injectable development, will have greater flexibility for successful manufacture of complex injectables in early phase development of therapeutic drugs.

  8. Decoding the FDA Guidance on Essential Drug Delivery Outputs 2/18/2025

    The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.

  9. Benefits Of Microparticle Technology For Oral Drug Solubility Enhancement 6/8/2022

    Spray-dried dispersions, hot-melt extrusion, and solubilizing excipients are common solubility enhancement techniques, but new developments to maximize amorphous solid dispersion benefits are needed.

  10. Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C

    This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.