Featured Articles

  1. 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.

  2. 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.

  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 Market Success For Pharma Partners From Concept To Patient

    The development of drug delivery devices that are innovative, intuitive, patient friendly, and patient safe must address certain areas of concern that are particular to both biologic and biosimilar therapies.

  5. 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.

  6. Selecting Container Closure Components: A Data-Driven Approach To CCI

    Discover an efficient, data-driven process that employs innovative methods to accelerate the selection of a closure containment system that meets the requirements of the modern regulatory landscape.

  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. Industry Trends In Biologic Formulations

    Major factors that are driving the market growth are next-generation business, high growth in chronic diseases, less expensive biosimilar drugs, and favorable government regulations.

  9. USP <382>: Think Systems, Not Components

    This blog focuses on the application of USP <382> prescribed testing to cartridges and syringes from a mechanical testing perspective.

  10. Early Decisions To De-Risk The Transition To Combination Products

    The injectable product development landscape is changing, and the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?