Featured Articles

  1. Is It Ever Too Soon To Start Your Performance Testing Assessment?

    Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.

  2. 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.

  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. 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.

  5. 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.

  6. 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.

  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. Key Considerations For Selecting Flexible Fillers

    Flexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.

  9. Stopper Functionality – Key Considerations

    When selecting the appropriate rubber stopper for any respective vial containment system, there are many aspects to consider regarding the properties of the elastomeric closure.

  10. Demystifying Performance Testing: Strategies To Qualify Combination Products

    Explore applicable regulations and guidances, and performance risks identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses.