Summary
Because the LUMC pharmacy is located adjacent to CHDR, investigational medicinal products can be prepared and delivered to our researchers quickly and efficiently, even after working hours to facilitate overnight trials. The pharmacy is fully GMP licensed for the import, manufacture, compounding, and dispensation of study drugs. The pharmacy also repackages, labels, randomises and codes the compounds used in our randomised clinical trials. The LUMC’s pharmacists work closely with both us and our sponsor throughout the design and execution of a clinical study, ensuring achievable timelines and helping to address issues as needed.
A state-of-the-art GMP-certified facility
At the LUMC pharmacy, more than 100 pharmacists and support staff produce, package, and deliver the thousands of pharmaceutical products used at the LUMC and CHDR. The pharmacy actually comprises two GMP-certified facilities − a GMP warehouse and a series of fully equipped laboratories for analysing medicinal compounds − meaning that they can deliver products that meet, or even exceed, the highest quality standards when preparing and packaging IMPs formulated to meet the sponsor’s specific needs.
The pharmacy contains eight class D clean rooms, and their sterile facility includes eight class C clean rooms and one class B clean room. In addition, their reconstitution facility contains three additional class D clean rooms.
A long-standing relationship
CHDR and the LUMC share a long history. CHDR’s first facility was located at the former LUMC pharmacy – in what was then known as Leiden University Hospital. Over the past three decades, as CHDR has grown, both the LUMC Pharmacy and the Analytical Laboratories at LUMC have grown with us, playing a central role in our studies. The expansion of the LUMC pharmacy, and particularly its GMP facilities, has also been driven by an increase in translational research at the LUMC.
CHDR and LUMC have a long-standing master service agreement, covering the business and legal aspects of the relationship as well as clinical and analytical activities. In addition to this overarching agreement, with each new study a specific contract is signed by all key parties, including the pharmacy, the sponsor, and CHDR.
