Injectable Drug Delivery Resources

  1. Addressing Glass Particulates In Injectable Drug Formulations

    Learn how a new vial design that is capable of reducing the propensity for glass particulate generation on filling lines is enabling a significant, positive impact on product quality and safety.

  2. 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.

  3. Is It Ever Too Soon To Start Your Extractables And Leachables Assessment?

    Learn what you need to know about planning for your extractables and leachables testing programs to mitigate delays to your drug development timelines.

  4. Delivering The Promise Of Gene Therapy 1/22/2024

    Gene therapies rely on efficient, precise methods of delivering genetic material. Examine how combining polymeric nanoparticles with CRISPR therapies is increasing the potential for improved treatment.

  5. Component Technologies For Cartridge Delivery Applications

    Current component technologies for cartridge-based drug delivery pose challenges. In order to address these challenges, the next generation of cartridge components are evolving.

  6. Compliance Considerations For Emergency-Use Delivery Systems 5/2/2022

    Because auto-injectors are typically the delivery device of choice for emergency medications, they come with increased scrutiny from regulatory bodies regarding their safety and effectiveness.

  7. The Impact Of PFAS Regulations On Drug Delivery Devices 7/29/2024

    By adopting a strategic approach and embracing necessary measures, the medical device industry can transform regulatory challenges surrounding PFAS into opportunities for innovation and growth.

  8. How Recent Trends Impact Bringing Your Molecule To Market 7/9/2024

    With accelerated approval times, growing competition between drugs, and a shift from hospital to home care, you’re under pressure to develop a delivery device in parallel with your drug.

  9. Evaluation And Identification Of Subvisible Particulate Matter In Injections

    Review the scopes of USP chapters <787> and <788>. Both chapters address injections and have the same regulatory requirements according to their nominal volumes for subvisible PM.

  10. Characterizing The E&L Profile Of Stoppers For Drug Stability 6/11/2024

    The significance of E&L testing lies in its ability to identify potential risks associated with the use of containers and packaging materials in the pharmaceutical industry.