Injectable Drug Delivery Videos

  1. Survival Kit For Quality Regulations: A Closer Look At Lyo Packaging

    Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.

  2. Overcoming Formulation Challenges For mRNA, High-Concentration Proteins

    Increased demand for protein delivery and the emergence of advanced modalities – including mRNA – are introducing new challenges to the development lifecycle, such as high-concentration formulations.

  3. Selecting Containers For Sensitive And Costly Cell & Gene Therapies

    Explore the challenges related to packaging of cell and gene therapy products and proven solutions to enable speed to market and compatibility, performance of packaging materials.

  4. Challenges Associated With In-Use Simulated Administration Of Biologics

    Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.

  5. FDA Guidance: Inspection Of Injectable Products For Visible Particulate

    A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.

  6. Managing Container Closure Related Complexities With Lyophilized Drug Products

    Using a comprehensive approach to component selection mitigates risks to fill-finish and lyo processing. Explore key considerations for selecting lyophilization stoppers suitable for intended use.

  7. Addressing Key Challenges Of High Concentration Formulation Development

    High concentration formulations often present challenges with regard to viscosity as well as potential changes in the behavior upon stability. Discover solutions to mitigate high viscosity.

  8. Regulatory, Cost Implications Of Switching Injectable Delivery Formats

    Launching a large molecule in one format and then switching the delivery format often transpires as a lifecycle management strategy for cost efficiency, supply chain continuity, and patient benefit. 

  9. A Data-Driven Approach To Container Closure Integrity

    Gain confidence in your container closure system selection by utilizing a stepwise and data-driven approach to predicting and verifying container closure integrity.

  10. EU Med Device Regulations: Ensuring Compliance For Integral Combination Products

    Review the EU Medical Device Regulation (MDR) changes, specifically with respect to integral combination products, and examine the technical documentation packages supporting functionality and content.