Featured Articles

  1. Best Practices For Ensuring Quality In Biologic Products

    New biologic therapies have new challenges in their packaging and delivery systems because of their complexities, higher stability risks, and larger sizes. 

  2. Guidelines For Selecting A Medical Device Contract Manufacturer

    Consider these guidelines when evaluating potential device contract manufacturers to choose one that will be the best fit for your company.

  3. 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.

  4. The Role Of The Contract Manufacturer In Medical Device Development

    With a trusted contract manufacturing partner, pharma companies can ensure that their innovative therapies come to market efficiently without compromising the quality of the drug and its delivery system.

  5. 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.

  6. NovaPure Stoppers - The Right Choice For Oncology Drugs

    Vial containment systems with NovaPure® elastomer stoppers offer substantial performance benefits with their enhanced dimension control, reduced particle levels, inspection of every stopper, and use of FluroTec® film. Explore the performance of the film and why NovaPure stoppers should be the choice for sensitive drug products.

  7. 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.

  8. 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.

  9. 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.

  10. The Importance Of A Human Centered Approach To Product Development

    To meet the needs of patients, life-saving device innovations are needed for the next generation of delivery devices. As drug manufacturers explore the device world, human factors are a key consideration.