Robotic reconstitution of cytostatic drugs and monoclonal antibodies: transforming aseptic drug compounding in hospital pharmacies

Geersing, T.H. (2025)

Doctoral Thesis

Hospital pharmacies face significant challenges: the demand for sterile drug reconstitutions is increasing, while specialized personnel remain scarce. Automation offers a potential solution, but its practical implementation in hospitals is still unclear. This dissertation examines the use of a compounding robot for cytostatics and monoclonal antibodies, focusing on product quality, cost-effectiveness, and safety.
Our study shows that both robotic and manual reconstitutions comply with Dutch pharmaceutical regulations and the European Pharmacopoeia. Stability and antibody aggregation are comparable, but the robot demonstrates lower variability and more consistent performance. The APOTECAchemo robot meets European GMP microbiological standards, and cytotoxic and non-cytotoxic drugs can be safely prepared in the same environment without cross-contamination.
We found that vials can be safely reused up to eight days after first access, reducing waste and costs. A combination of manual and robotic reconstitution doubles production per full-time equivalent (FTE), lowering direct labor costs by 2.5 times compared to manual reconstitution alone.
Our findings highlight the value of compounding robots in hospital pharmacies, enhancing drug reconstitution quality and efficiency while reducing costs and environmental impact. This enables pharmacies to meet growing healthcare demands without increasing personnel requirements.

• Hospital pharmacy
• Sterile drug reconstitution
• Automation
• Compounding robot
• Cytostatics and Monoclonal antibodies
• Cost-effectiveness
• Good Manufacturing Practice (GMP)
• Environmental safety
• Healthcare efficiency

• All authors: Geersing, T.H.
• Supervisor: Knibbe, C.A.J.
• Co-supervisor: Crul, M. Franssen, E.J.F.
• Committee: Lange, E.C.M. de; Irth, H.; Schimmel, K.J.M.; Nejadnik, M.R.; Beijnen, J.H.; Barz, M.
• Qualification: Doctor (dr.)
• Awarding Institution: Leiden Academic Centre for Drug Research (LADCR), Faculty of Science, Leiden University
• Date: 2025-03-19
• ISBN (print): 9789465104959
• Sponsorship: The printing of the research was financially supported by the Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie (KNMP)