The LUMC Pharmacy: a full-service partner in early-stage clinical research

The Pharmacy at Leiden University Medical Centre (LUMC) prepares and delivers the pharmaceutical products used by CHDR, including investigational medicinal products (IMPs). This Good Manufacturing Practice (GMP)-licenced pharmacy offers tailor-made solutions to help answer our sponsors’ questions.

Highlights

  • Because the LUMC pharmacy is located adjacent to CHDR, IMPs are prepared and delivered to our researchers quickly and efficiently, even after hours, thereby facilitating overnight trials.
  • The Pharmacy is fully GMP-licensed for importing, manufacturing, compounding, and dispensing study drugs.
  • The Pharmacy also repackages, labels, randomises, and codes the compounds used in our randomised clinical trials.
  • LUMC’s pharmacists work closely with CHDR and the sponsor throughout the design and execution of the clinical study, ensuring that the timeline is feasible and helping address issues as needed. A long-standing relationship

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. Because the Pharmacy is actually two GMPcertified facilities − a GMP warehouse and a series of fullyequipped laboratories for analysing medicinal compounds − 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 LUMC have a long history. CHDR’s first facility was actually located at the former LUMC pharmacy in what was then called Leiden University Hospital. Over the past 25 years, as CHDR grew, both the LUMC Pharmacy and the Analytical Laboratories at LUMC have grown with us, playing a central role in our studies. At the same time, the LUMC Pharmacy has also grown − particularly the GMP facilities − in order to keep up with the increase in translational research at the LUMC. 

CHDR and LUMC have a long-standing master service agreement, which covers the business and legal aspects, as well as our clinical and analytical activities. In addition to this general, overarching agreement, with each new study a specific contract is signed by all key parties, including the Pharmacy, the sponsor, and CHDR.

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