Injectable Drug Delivery Resources

  1. Container Closure Integrity: A Risk-Based Approach

    Container closure integrity is essential to protecting drug product and satisfying regulatory agencies. A risk-based approach enables creation of a robust data file for timely approval of regulatory applications.

  2. Evaluating A Novel Cyclic Olefin Polymer Container System For Storing AAV 7/20/2023

    This study investigates the suitability of a container system composed of the novel COP CZ as an alternative for the ultra-cold storage of therapeutically relevant AAV viral vectors.

  3. Prioritize Your Finished Goods Experience To Safely Deliver Medicine

    As demand forecasts evolve, opt to work with a CDMO that can pivot manufacturing strategies seamlessly while accommodating your end-to-end needs, from drug substance to finished goods.

  4. Mitigating Particulate Risk In Injectables

    What are the sources of such particulates in injectables, and how should manufacturers apply the latest regulations to ensure best practice when producing sterile drug products?

  5. Considerations In Formulation Development Of Injectable Solutions 2/8/2022

    Injectable solutions offer an alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability, and suitability of administration under hospital setting.

  6. Is The Autoinjector Dead? The Future Of Patient-Centered Drug Delivery 9/1/2025

    Autoinjectors revolutionized drug delivery, but innovation is shifting toward oral, wearable, and alternative platforms. Future focus emphasizes patient experience, sustainability, and broader drug delivery toolkits beyond the autoinjector.

  7. Stability Chambers: Testing, Equipment, And Uses 3/7/2023

    Performing stability studies is a critical step in the drug development process. Discover the ways to ensure that your drug is safe and effective as it goes to market.

  8. Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials 5/24/2024

    The Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.

  9. Container Closure Integrity Evaluation For Cell And Gene Therapies

    With the growth of gene and cell therapies, there is an increased need to characterize container closure systems at the low temperatures experienced during their lifecycles.

  10. Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal Combinations 9/3/2024

    The study was designed to investigate CCI over a period of 24 months at ambient, ultra-low and cryogenic temperatures for serum-stopper samples and at ambient temperature for lyo-stopper samples.