Featured Articles

  1. Gene Therapy: Maintaining Sterility At Low Temperature Storage

    A gene therapy for pediatric Spinal Muscular Atrophy required a leak and break-resistant container which maintains sterility over product shelf life, through freeze and defrost cycles.

  2. 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. 

  3. 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.

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    Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.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

  6. USP <382>: Think Systems, Not Components

    This blog focuses on the application of USP <382> prescribed testing to cartridges and syringes from a mechanical testing perspective.

  7. 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.

  8. FDA Hopes To Spur More ANDA Pre-Submission Meetings During GDUFA III

    The FDA believes a pre-submission meeting when a complex generic application has unusual elements will lead to more first-cycle approvals. Learn more communication enhancements in GDUFA III.

  9. 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.

  10. The Path To Commercialization For Wearable Drug Delivery Devices

    Explore the evolution of the wearable drug delivery market, including the route to commercialization and the challenges faced.