ON-DEMAND WEBINARS

Explore the pros and cons of marketed amorphous solid dispersions with so-far unpublished data as well as a green alternative to ASDs: best-in-class nanotechnology to manufacture nanocrystals.

Review the EU Medical Device Regulation (MDR) changes, specifically with respect to integral combination products, and examine the technical documentation packages supporting functionality and content.

Explore how our on-body delivery system supports high-volume biologic delivery by balancing usability, patient needs, and sustainability through research-driven design.

Using a comprehensive approach to component selection mitigates risks to fill-finish and lyo processing. Explore key considerations for selecting lyophilization stoppers suitable for intended use.

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

  • Unpacking The FDA Draft Guidance On Container Closure Systems

    In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems. She also addresses the integration of CCS guidance into the development organization’s QMS (Quality Management System).

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DRUG DISCOVERY CONTENT COLLECTIONS

Why Human Factors Are Critical To Drug Delivery Device Success

In today’s highly competitive biopharma market, successful therapies prioritize the patient experience. Increasingly, patients expect to receive advanced therapies at home or in decentralized care settings, which require delivery methods that are easy to use and comfortable.

This collection explores how drug delivery teams can incorporate patient-centricity across development, from early human factors strategies to modality selection, ensuring safe, effective therapies that translate to real-world care.

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