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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.

A highly concentrated non-aqueous suspension of an IgG1 was developed using a patented platform. Review how the particle size of the mAb impacts the overall behavior of the drug product.

Discover how revolutionary and environmentally sustainable nanoparticle technologies coupled with innovative formulation approaches can address drug solubility issues and add value for patients.

Discover how to advance new compounds with complex chemistry through each stage of development by refining processes to give fit-for-purpose manufacturability and yields.

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    In this article, Fran DeGrazio discusses the FDA’s draft guidance on container closure systems for biosimilar products.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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