This case study explores the deployment of an innovative logistics solution designed to support the survival of premature infants through the rapid collection, retrieval and delivery of essential, temp-sensitive supplements to hospitals in Sydney, Australia.
Storage specifications for the supplements was -20°C with instant availability required upon order. Retrieval was immediately followed by expedited delivery at -80°C with dry ice. Executed by Marken, this project required a comprehensive system enabling immediate access, and transportation of these critical supplements, ensuring they reach newborns in regional hospitals when every second counts.
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
PharmTech spoke with Tara Dougal, event director for pharma at Informa Markets, about trends impacting the pharmaceutical industry and how CPHI Milan is addressing these areas this year.
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.