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A practical framework for planning and justifying design verification programs for prefillable syringes, covering test selection, acceptance criteria, and sample-size rationale within a risk-based approach.

Nanoparticle engineering enabled a 440 mg/mL trastuzumab suspension that clears viscosity and stability barriers limiting conventional high-dose subcutaneous biologics formulations.

Explore an integrated workflow for targeted lipid nanoparticle development, covering ligand conjugation, candidate screening, and scalable manufacturing for cell-specific nucleic acid delivery.

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.

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    In this article, Fran DeGrazio discusses the FDA’s draft guidance on container closure systems for biosimilar products.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