Clinical Pharmacy and Pharmacology
GMP translation and production of tracer for clinical trials is performed in collaboration with the Department of Clinical Pharmacy and Pharmacology (CPP) of the UMCG. The department of CCP is responsible for providing pharmaceutical care to patients admitted to the UMCG, as well as providing GCP and clinical trial support for the clinic, performing pre-clinical and clinical pharmaceutical research and teaching and education at the University of Groningen. The department is ISO9001 certified (including NTA8009), possesses a GMP manufacturing licence and complies with GCP. The laboratory unit has been accredited according to ISO 15189. Activities of the department include the distribution of medication, compounding of personalized drug dosage forms, total parenteral nutrition and high-risk medication as well as drug bioanalysis, therapeutic drug monitoring and toxicological analysis.
Tracer development and production
Tracer-related production and physico-chemical analytical work is performed by the unit Special Products of the CPP. This unit focuses on innovative short-term projects, especially when translation from a lab-setting to the clinical trial phase is involved. Special Products is involved with several other units of the CPP, and has access to Class A LAF-hoods in both Class C and Class B cleanrooms in order to perform bulk material production and aseptic filling of proteins, peptides and other products. The laboratory is equipped with a range of techniques such as UV-VIS spectrophometry, HPLC, GC, ELISA and an assortment of Ph.Eur. compendial analyses in order to perform quality control. Produced material is subject to Quality Control and release by responsible PharmD’s of the Production and Laboratory Units before undergoing full QP review and release for use in clinical trials.
The Unit Special Products also assists in the establishing of documentation and (IMP) dossier building during development, GMP translation and the lifecycle of the product, such as development reports, technology transfer reports and investigatory medicinal product dossiers (IMPD). Deviations and changes are documented according to the internal quality system of the department of CPP in deviations and change controls.
Through input from and collaboration with the OMIG research group, the Unit Special products has performed the full development and clinical translation of two monoclonal antibodies conjugated to the near-infrared fluorescent dye IRDye 800CW. These antibodies are currently used in clinical trials. The unit keeps in close contact with the clinical researchers to evaluate the performance of the existing products and improve where needed. Additionally, this close contact enables the evaluation of the clinical needs and exploration of interesting research opportunities where additional tracer development is needed.