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. Ophthalmic Drug Delivery: Meeting Modern Challenges With A Next Generation Solution 8/17/2026

   Ophthalmic injectable packaging demands early strategic attention. Learn how silicone oil contamination, particulate limits, and dosing accuracy challenges can derail development programs and what it takes to stay compliant.

7. The Clear Solution: Navigating Contamination Control For Ophthalmic Injectables 8/12/2026

   As the intravitreal therapy market grows and applicable regulations evolve, continued compliance demands technological savvy and rigorous contamination control.

8. 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.

9. 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.

10. 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.