Featured Articles

  1. 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.

  2. Functional Performance Of Stoppers To Support Multipuncture Use

    Multi-dose vials enable dosing flexibility to a diverse group of patients with different dosages dependent on patient age/weight and can create efficiency and reduce packaging waste when vaccines are administered to large populations.

  3. 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.

  4. De-Risking Visible Particles Through Component Selection

    Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.

  5. Create An Effective Risk Management Program

    Drug-device combination products are rapidly increasing in use, based on their numerous benefits. This article is a review of achieving performance and regulatory compliance for their successful development and commercialization.

  6. Selecting A Vial Container Closure System With The DeltaCube™ Modeling Platform

    Understand a system approach that facilitates data-driven selection and optimization of vial container closure system components.

  7. Container Closure Integrity: A Risk-Based Approach

    Container closure integrity is essential to protecting drug product and satisfying regulatory agencies. A risk-based approach enables creation of a robust data file for timely approval of regulatory applications.

  8. Reliable Components For The Lifecycle Of Your Injectable Drug Product

    As drug products increase in complexity, become more specialized, and trend towards self-administration, it is more important than ever to have a reliable drug closure system.

  9. 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.

  10. 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.