A US biopharmaceutical company approached Almac to assist with the EU product launch of their high value, orphan drug product. As the drug product was temperature sensitive with minimal allowable temperature excursions a key deliverable of the project was to design and qualify a temperature controlled shipping solution to ensure delivery of the production optimum condition. Throughout this case study Almac will highlight the challenges that arose and will provide solutions on how these challenges were overcome to facilitate a successful product launch.