Injectable Drug Delivery Resources

  1. Contract Design And Development Vs. In-House: How To Find The Best Fit 3/21/2024

    Explore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.

  2. 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.

  3. 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.

  4. Annex 1 – The Brave New World Of Regulatory Compliance 2/3/2023

    The revision to Annex 1 will become effective in August 2023. Explore the major changes and considerations along with the next steps to achieve Annex 1 Regulatory compliance.

  5. 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.

  6. How Oral GLP-1 Therapies Are Revolutionizing Obesity Treatment 2/3/2025

    The rising incidence and severity of obesity have amplified a therapeutic need in healthcare. Read more about Dr. Srinivasan Shanmugam discussing the challenges and impact of GLP-1 analogs.

  7. Ready-To-Use Cartridges: Ensuring Compatibility For GLP-1-Based Drugs 8/27/2024

    Ready-to-use cartridges for GLP-1 applications offer safe, reliable self-administration. See how they can minimize complexities and better align with the stringent demands of modern manufacturing.

  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. Applying Automation To The Manufacture Of Drug Delivery Devices 7/12/2023

    Automated manufacturing is a powerful but often misunderstood tool available to produce drug delivery and other pharmaceutical devices — whether established designs or innovative new ideas.

  10. Plan For Your Extractables And Leachables Studies To Meet Submission Timelines

    Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission.