In this article, Chief Editor Tom von Gunden considers the relationship between regulatory testing and the biopharma industry’s interest in leveraging drug delivery platform technologies to reduce regulatory burden in product development. Tom includes a conversation with guest columnist Doug Mead about waivers on testing in the context of FDA’s guidance on Essential Drug Delivery Outputs (EDDOs).
This disposable pen for semaglutide is a generic drug-device combination, designed for usability and regulatory compliance, showing comparable performance to the reference device.
Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.
Hear from experienced professionals in the drug delivery space on how to ensure success and speed-to-market by establishing a firm foundation when working with a CMO.
By Otto Abildgaard and Lars Keinicke Hansen, Stevanato Group
Shift from static lines to modular assembly. Combining intelligent software with plug-and-play hardware enables rapid format changes, shortens validation, and unlocks data for scalability.
When component lead times don’t align, inventory piles up, cash gets tied up, and forecasts can quickly turn into waste or shortages. What if a single integrated PFS system could simplify it all?
Antibody‑drug conjugate services support development from early clinical stages through commercial manufacturing with integrated analytics, containment expertise, and scalable conjugation capabilities.
GLP‑1 therapies are changing injectable care and driving rapid progress in delivery and manufacturing. See how patient needs, emerging tech, and regulations are reshaping chronic treatment.
