Injectable Drug Delivery Resources

  1. Wearable Injectors: An Alternative To Traditional Intravenous Administration 3/24/2022

    See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.

  2. Faster From Formulation To Fill/Finish 7/12/2022

    Optimize your speed to clinic by securing a development and aseptic fill/finish partner to support your applications with the right manufacturing equipment, communications, and SOPs.

  3. 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.

  4. 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.

  5. Maintaining Superior Viral Vector Recovery In Cell And Gene Therapy Applications 9/3/2024

    A study assessing the stability of vials aimed to determine if the vial material had any influence on the viral titer and particle counts of the AAV serotypes.

  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. Steps To Overcome Challenges Associated With Biologic Formulation Development 8/24/2022

    Explore guidance on the challenges posed by biologics, including overcoming degradation, establishing a stress test process, and the value of lipid nanoparticles (LNPs) and polymeric nanoparticles (NPs).

  8. Understanding Injectable Drug Container Closure Systems 6/20/2024

    Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.

  9. 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.

  10. PFAS In Medical Devices: Expert Insights On Frequently Asked Questions 1/2/2025

    Watch to learn more about PFAs in medical devices, covering environmental concerns, health risks, testing, alternatives and management strategies with Shalene Thomas of Battelle.