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. Comparing Vial Container Closure Systems

    Examine a case study where two 20mm vial CCSs were compared using the DeltaCube™ Modeling Platform and experimentally show the link between prediction and real performance.

  3. The Largest LOE Event In US Pharma History

    Ahead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.

  4. Evaluate CCI Of Vial And Syringe Systems Over Time And Temperature

    Combining techniques, such as Residual Seal Force, tracer gas analysis, and headspace analysis, enables a more complete and quantified measure of CCI for vial and syringe combinations.

  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. Packaging/Delivery System Integrity And Self-Sealing Capacity Of Vial Systems

    Review the scope and testing procedures required by General Chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems.

  7. 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.

  8. Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C

    This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.

  9. How To Address Challenges In Oncology Drug Containment

    Drug product containment systems comprising Daikyo Crystal Zenith® cyclic olefin polymer (COP) vials, matched with NovaPure® stoppers, offer container closure integrity (CCI) performance that has been quantified for oxygen and carbon dioxide, and they have excellent system performance. 

  10. 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.