Injectable Drug Delivery Resources

  1. Reliable Components For The Lifecycle Of Your Injectable Drug Product

    As drug products increase in complexity, become more specialized, and trend towards self-administration, it is more important than ever to have a reliable drug closure system.

  2. Meeting The Growing Demand For Pre-Filled Syringes 3/7/2023

    The market for pre-filled syringes is growing rapidly. Learn more about the benefits for consumers, providers, and manufacturers, and the importance of partnering with a reliable fill finish facility.

  3. Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination Products

    As the benefits of delivering biologic drugs as part of a combination product platform are realized, this self-administration trend will continue to grow. From a regulatory perspective, the use of a risk-based approach is foundational.

  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. Improve Speed To Market By Mitigating Vial And Stopper Incompatibility 10/1/2024

    These studies indicate that with a properly assembled vial containment system, good CCI performance can be achieved with stoppers of a given elastomer, independent of configuration/size, or vial style.

  6. A Lifecycle Management Strategy For Sterile Injectables 12/9/2022

    Gain insight into the benefits and challenges of transferring a therapeutic compound from one aseptic injectable format to another.

  7. Lyophilization vs. Liquid Formation: Why Lyo Offers Advantages 3/8/2022

    Lyophilization offers some alluring advantages in today’s complex market, but its challenges require innovation and expertise to surmount.

  8. 4031 Ready Methods Reduce E&L Timelines

    An established approach for executing extractables and leachables evaluations for individual drug products comprises understanding risks, developing and validating targeted leachables studies, and supporting drug products through stability testing.

  9. 10 Ways To Align Your Medical Device With Human Factors Industry Best Practices 3/1/2024

    Discover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.

  10. Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway 1/24/2022

    Revitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.