Articles, App Notes, Case Studies, & White Papers

  1. From Innovator To Partners In Cell Therapy: Our Evolution Into A CDMO

    Explore the common pitfalls encountered in CGT CDMO collaborations, including communication breakdowns, differing regulatory interpretations, and program prioritization challenges.

  2. 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.

  3. Capsule Formulation Development: From Dosage Forms To Filling 5/4/2022

    Capsules are tasteless and easy to take, offer streamlined development timelines, and simplicity of manufacturing. Discover capsule formulation development and the benefits of capsule dosage forms.

  4. Integrated Strategies for Achieving Regulatory Milestones Faster 10/12/2023

    Learn how an innovative formulation platform reduced development timelines and allowed a sponsor to find the optimal nafamostat formulation without adding unnecessary delays.

  5. Are Drugs Becoming More Lipophilic Over Time?

    Get a deeper look into how drug lipophilicity has evolved over time, its impact on drug development, and the need for new technology to enable new more complex drugs.

  6. A Solvent-Free, Fusion-Based ASD Manufacturing Process 3/5/2024

    Explore a solvent-free alternative for the production of amorphous solid dispersions (ASDs) that not only improves manufacturability but also reduces the carbon footprint of ASD manufacturing.

  7. Understanding The In-Vitro/In-Vivo Relationship (IVIVR): Inhaled Medicinal Products 11/8/2021

    IVIVR modeling leverages in-vitro testing knowledge toward predicting in-vivo testing results, often reducing long-term development costs by facilitating more informed decision-making during drug development.

  8. The Dynamic Regulatory Environment Of Drug-Device Combination Products 11/29/2022

    Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.

  9. How To Protect A Modern Silicone Oil-Sensitive Biologic Drug For Self-Injection Of 2.25mL 4/25/2023

    A customer experienced expensive project delays when they selected their “tried and tested” large volume, glass syringe system to package a drug to be used in an auto-injector for self-administration.

  10. The Importance Of An Analytical Testing Strategy

    A proper and well-thought-out combination product testing strategy, rooted in applicable guidances in sync with scientifically sound methods, data capture, and reporting and retainment, is critical.