ON-DEMAND WEBINARS

Through case studies on modified release, poor solubility, and pediatrics, discover how integrating GMP manufacturing and clinical testing can rapidly accelerate development timelines for even the most challenging of molecules.

Strengthen risk mitigation strategies while ensuring regulatory alignment. Gain valuable insights into best practices and proactive approaches for building a robust and future-ready CCS.

Gain confidence in your container closure system selection by utilizing a stepwise and data-driven approach to predicting and verifying container closure integrity.

Modular suites with built-in contamination control streamline sterile manufacturing—supporting complex products, faster timelines, greater flexibility, less disruption, and scalable fill‑finish.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

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Fran DeGrazio, Executive Editor - Drug Delivery Leader & Frankly Fran

Fran offers keen industry and technical insights exclusively on Drug Delivery Leader.

DELIVERED BY DEGRAZIO

  • Container Closure Systems For Biosimilars: Is There Regulatory Difference?

    In this article, Fran DeGrazio discusses the FDA’s draft guidance on container closure systems for biosimilar products. She highlights key takeaways and offers recommendations on implications that developers of biosimilar pharmaceutical products should consider in areas such as quality, testing, and documentation.

EDITORIAL COLLECTIONS KNOWLEDGE CENTER

Our Editorial Collections examine today’s biggest scientific, operational, and patient-centered drug delivery issues. These collections help companies navigate complex development decisions with in-depth analysis, real-world examples, and guidance from industry experts.

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