Featured Articles

  1. 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.

  2. 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.

  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. Benefits Of QbD: Considerations For Drug-Device Combination Products And Partnerships

    Quality by Design (QbD) achieves quality through understanding of all components and processes, with a detailed understanding of risks and how they can be mitigated.

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    Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.

  6. 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.

  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. 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.

  10. Indian Regulatory And Industry Bodies Call For Open Dialog With Policymakers

    Discover how the Indian Pharmaceutical Alliance saw regulatory bodies call for policy intervention to provide support and incentives for innovation and R&D in the Indian pharmaceutical sector.