11.07.26 -- Drug Delivery Leader Best Of October

In this article, Fran DeGrazio discusses the FDA’s draft guidance on container closure systems for biosimilar products.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

In this episode of Supplier Horizons, host Tom von Gunden discusses with Chief Scientific Officer Ying Tam from LNP platform developer Acuitas Therapeutics the use of lipid nanoparticles as RNA delivery vehicles across an expanding range of targetable indications, including outside the liver. Among the advances discussed are delivering CAR-T therapies in vivo, loading personalized therapeutic payloads into preformed vesicles, and maintaining RNA stability throughout targeted cellular delivery.

Platform selection for long-acting injectables is increasingly complex because therapeutic modalities, delivery systems, and target product expectations have all diversified. Can your selected platform meet the needs of your product?

Modern sterile manufacturing requires proactive quality risk management. Robust contamination control across facilities, processes, and supply chains supports compliance and patient safety.

Establishing unified component standards through collaborative innovation eliminates unnecessary investment, reduces development timelines, and ensures scalable, patient-centered delivery systems.

As nasal therapies advance, integrating formulation, device, manufacturing, and regulatory planning early helps reduce risk, accelerate launch, and support patient outcomes.