Featured Articles

  1. Planning For Scale Up: Building For Long Term Flexibility 8/31/2026

    Decisions made during clinical manufacturing have lasting consequences at commercial scale. This article examines how fill/finish equipment choices shape long-term flexibility, throughput, and operational continuity.

  2. Minimizing Particulate Risk: Designing For Control 8/31/2026

    Effective particulate control in aseptic fill/finish operations requires coordinated design decisions spanning airflow configuration, static mitigation, transport mechanisms, and closure handling.

  3. Protecting Your Drug Product: Integrating Engineering And Quality 8/31/2026

    Engineering decisions in fill/finish directly shape product quality and sterility assurance. This article examines how inert gas purging, plunger placement, dosing verification, and barrier systems interact across line design.

  4. Establishing A Container Closure System — Engineering For Integrity 8/31/2026

    CCS design in aseptic manufacturing involves more than component selection. This article examines how elastomeric closures, barrier configurations, component formats, and plunger placement affect integrity and line performance.

  5. Start Packaging Development Early: De-Risk Before You Build 8/31/2026

    When packaging development follows fill/finish line selection rather than informing it, teams face avoidable retrofits and delays. This article examines why earlier alignment changes outcomes.

  6. Mechanical Engineering Design Process For Combination Products 7/17/2026

    Mechanical engineering for combination drug-delivery devices demands more than good design — it requires data-driven risk management from specs through simulation. Learn how a structured phase approach ensures global manufacturing readiness.

  7. Considerations In Design And Development Of Novel Combination Drug-Delivery Devices 7/17/2026

    Poor scoping kills drug delivery device programs before they start. Learn how to define the right problem, assess risk early, and set boundaries that protect your timeline and budget.

  8. USP Draft Chapters On CCS: What You Need To Know 5/12/2026

    Learn why it's important to stay aligned with evolving Annex 1 expectations to support sterility assurance, regulatory compliance, and patient safety across sterile drug manufacturing operations.

  9. USP <788> Revisions And Why Packaging Matters More Than Ever 5/12/2026

    Prepare for the upcoming USP <788> revisions by strengthening your particulate control strategy to support regulatory compliance, product quality, and patient safety across injectable drug products.

  10. Why Lower Endotoxin Levels Matter: Raising The Bar For Patient Safety And Product Quality 5/12/2026

    Strengthen patient safety and regulatory compliance with comprehensive endotoxin control strategies designed to support the evolving demands of injectable and advanced pharmaceutical products.