Newsletter | April 28, 2025

04.28.25 -- Platform Approaches To Personalized Medicines

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Join experts in drug delivery innovation as they discuss advancements in long-standing devices, systems, and platforms. Covering technologies like autoinjectors, infusion pumps, OBS, combination products, and connected devices, this virtual panel discussion will explore technical and functional innovation needs, challenges, and successes. Register today for Drug Delivery Leader Live happening May 7th!

FEATURED EDITORIAL

Platform Approaches To Personalized Medicines

Chief Editor Tom von Gunden talks with CEO Dominik Witzigmann of LNP platform developer NanoVation Therapeutics about patient needs, biopharma partnering, and the regulatory landscape.

The Regulatory Intent Of A URRA For Combination Products

In this segment on human factors risk analysis, panelist Shannon Hoste offers insights on what the FDA is looking for when reviewing URRA (Use-Related Risk Analysis) compliance.

INDUSTRY INSIGHTS

Considering The Revised EU GMP Annex 1 For Sterile Medicinal Products

The revised Good Manufacturing Practice Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity.

Emerging Unit-Dose And Bi-Dose Nasal Sprays

Nasal spray administration of medicine offers advantages over oral and IV delivery. Experts discuss the advantages and opportunities of adopting unit- and bi-dose nasal delivery technology.

Enabling Subcutaneous Delivery For Improved Patient Compliance

The ability to administer high doses of biologics subcutaneously offers numerous benefits, including reduced treatment burden, improved patient convenience, and increased adherence.

Wearable Injectors: An Alternative To Traditional Intravenous Administration

See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.

Formulating Enteric-Coated Capsules For Controlled Release

Enteric polymer coatings play a crucial role in oral drug formulations, protecting the API from harsh gastric conditions and enabling targeted drug delivery with optimized release based on location.

SOLUTIONS

Science And Technology Innovation And Healthcare Application

Autoinjector For Deep Intramuscular Delivery