Articles, App Notes, Case Studies, & White Papers

  1. Navigating PFAS In Medical Devices 7/29/2024

    Review how an experienced partner can help you navigate the shifting regulatory landscape for your medical device.

  2. Parenteral Packaging And Delivery Systems: Container Closure Integrity

    Review the chapter, USP <1207> Package Integrity Evaluation – Sterile Products, which covers CCI and different methods of selection and validation.

  3. Successful Industrialization Requires Solid Foundations

    Learn how choosing the appropriate quality of containment systems from the outset is critical to the successful industrialisation of an injectable drug product and review some of the associated challenges.

  4. FAQs On The Revised EU GMP Annex 1: Volume 3 9/21/2025

    The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.

  5. Exploring Lipid Nanoparticles For Drug Delivery 11/11/2022

    Using lipid nanoparticles (LNP) for drug delivery is a promising area of research. Discover the benefits of LNP delivery, the different types of lipid nanoparticles, their safety for drug delivery, and more.

  6. Ophthalmic Drug Delivery: Meeting Modern Challenges With A Next Generation Solution 8/17/2026

    Ophthalmic injectable packaging demands early strategic attention. Learn how silicone oil contamination, particulate limits, and dosing accuracy challenges can derail development programs and what it takes to stay compliant.

  7. Key Financial Considerations For Phase II Clinical Injectable Drug Manufacturing 9/9/2022

    This article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.

  8. Advancing A LNP Formulation To Clinical And Commercial Manufacturing 3/25/2024

    Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.

  9. Have You Selected The Right Stopper For Your Lyophilized Drug Product?

    Component selection is a complex process. Packaging considerations should occur concurrent with drug development to mitigate risk at every step of the drug development process.

  10. Why Connect An Auto-Injector To A Smartphone?

    Why would a person with diabetes want to link their auto-injector to the Internet? Given that smartphones are so central to our everyday lives, it could be argued that the better question is: Why not?