Featured Articles

  1. Streamlining Primary Container And Device Selection With Predictive Calculations

    Expolore a theoretical approach to complement experimental approaches to more quickly select a packaging and delivery system for your drug product.

  2. 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.

  3. Industrialization And Scale-Up Of Drug Delivery System

    A pharma company and its product design partner were in need of a contract manufacturer able to support its device development, injection molding, tooling, logistics, and scale-up automation strategy. 

  4. 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.

  5. Addressing Glass Particulates In Injectable Drug Formulations

    Learn how a new vial design that is capable of reducing the propensity for glass particulate generation on filling lines is enabling a significant, positive impact on product quality and safety.

  6. 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.

  7. 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.

  8. Design Success Combined With Expertise In Testing And Raw Material Selection

    Learn more about improvements and optimized benefits across the packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.

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    Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.

  10. Successful Industrialization Requires Solid Foundations

    Learn how choosing the appropriate quality of containment systems from the outset is critical to the successful industrialisation of an injectable drug product and review some of the associated challenges.