Featured Articles

  1. Selecting A Strategic Partner For Your Combination Product

    It is imperative to choose an experienced partner that can ensure the highest quality products, minimize supply chain disruptions, and efficiently bring safe, effective drug products to patients.

  2. Key Considerations For Selecting Fill/Finish Manufacturing Technologies

    Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.

  3. Extractables And Leachables – Assessing Risk In A Complex Landscape

    It is not surprising that there is still confusion on the extractable and leachable topic. Guidances, where available, do not give step by step instructions on testing.

  4. Container Closure Integrity Evaluation For Cell And Gene Therapies

    With the growth of gene and cell therapies, there is an increased need to characterize container closure systems at the low temperatures experienced during their lifecycles.

  5. Trends In Combination Products

    As demand grows for more patient-centric drug delivery via self-administration, combination products are on the rise. Explore three major regulatory themes to consider when producing drug/device combination products.

  6. Maximize Global Regulatory Collaboration

    When marketing a combination product globally, pharmaceutical manufacturers and drug delivery technology providers must have a collaborative infrastructure based on strategic alignment, proactive regulatory awareness, lifecycle support, and continuous improvement globally.

  7. When Glass Vials Fail At Low Temps, Consider A Cyclic Olefin Polymer System

    If the glass vial for a biologic drug experiences breakage, or does not maintain container closure integrity, a cyclic olefin polymer (i.e., Daikyo Crystal Zenith COP) system may be the solution.

  8. 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.

  9. Parenteral Packaging And Delivery Systems: Container Closure Integrity

    Review the chapter, USP <1207> Package Integrity Evaluation – Sterile Products, which covers CCI and different methods of selection and validation.

  10. Reduce Costs And Improve Adherence For Self-Administration Of Biologics

    There is a growing trend toward wearable injectors for bolus delivery in order to help improve adherence and lower the costs of therapy.