Featured Articles

  1. Key Considerations For Selecting Flexible Fillers

    Flexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.

  2. The Path To Commercialization For Wearable Drug Delivery Devices

    Explore the evolution of the wearable drug delivery market, including the route to commercialization and the challenges faced.

  3. 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.

  4. 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.

  5. Demystifying Performance Testing: Strategies To Qualify Combination Products

    Explore applicable regulations and guidances, and performance risks identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses.

  6. A Proactive Approach To Reducing Particulate Risk

    A biotech that manufactures injectable large molecules was seeking to evaluate elastomeric components that would help them to attain the highest quality standards for their manufacturing lines.

  7. 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.

  8. Gamification: The Answer To Pharma's Non-Adherence Crisis?

    Digital connectivity is transforming the consumer experience and digital technology can now improve the patient experience too, in ways that were just not possible before.

  9. Your Approach To USP <382> For Your Drug Product Packaging

    The USP requirements for elastomeric components of container closure systems used for parenteral products are changing. Explore the implications for vial, syringe, and cartridge container closure systems.

  10. Testing For Parenteral Packaging And Delivery Systems

    There are many aspects to consider when developing a sound approach to performance testing to qualify packaging and delivery systems, and combination products.