Featured Articles

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. Implementing Medium And High-Volume Drug Handling And Packaging Programs 4/23/2026

   Simplify the complexity of combination product development by partnering for integrated support across device design, industrialization, manufacturing, and final product assembly.

7. Robotics And AI In Pharma: Driving The Next Wave Of Innovation 2/23/2026

   Adopting AI and robotics enhance sterility and regulatory compliance and enable real-time decision-making and reduce human-borne contamination, ensuring the safe production of complex therapies.

8. Extractables And Leachables: A Critical Part Of CCS Under EU GMP Annex 1 2/4/2026

   Managing chemical migration from packaging and process equipment is essential to protect patient safety, maintain drug stability, and ensure regulatory compliance.

9. FAQs On The Revised EU GMP Annex 1: Volume 7 2/4/2026

   Modernize your sterile manufacturing approach. Explore essential insights on contamination control strategies, risk management, and barrier technologies to ensure full regulatory alignment.

10. FAQs On The Revised EU GMP Annex 1: Volume 8 2/4/2026

    Successfully implementing a site-wide CCS requires prioritizing barrier technologies, integrating primary packaging into risk assessments, and adopting a data-driven approach to environmental monitoring.