ON-DEMAND WEBINARS

A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.

Explore the pros and cons of marketed amorphous solid dispersions with so-far unpublished data as well as a green alternative to ASDs: best-in-class nanotechnology to manufacture nanocrystals.

If you are in the process of developing a complex or sensitive injectable drug, learn about containment solutions to mitigate your risks and help you get your drug to the patient faster.

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

  • From Vial To Prefilled Syringe: Mastering The Development Transition

    In this article, Fran DeGrazio discusses the opportunities, challenges, and benefits for biopharmaceutical product developers in transitioning from vial-based to prefilled syringe (PFS) delivery approaches. She lays out key differences and added complexities in areas such as device functionality, risk management, regulatory pathways, use of materials, lifecycle management, and organizational alignment.

FREE EBOOK: COMBINATION PRODUCTS

Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.