GMP facility

The department of Clinical Pharmacy and Pharmacology of the UMCG has an extensive unit dedicated to production and preparation of drugs for the individual patient. Within the department cleanrooms of several different classifications are available for aseptic preparation of sterile products for human use. The department is licenced to produce medication for use both in- and outside of the hospital, and complies with cGMP and Ph. Eur. legislation. It supplies the wards of the UMCG with total parenteral nutrition, antibiotic and antifungal drugs and several other IV medications that can not be prepared at the bedside. Additionally, the compounding unit produces personalized medication for those cases where a registered drug does not fulfill the requirement of the physician and the patient.

 

The unit Special Products

The unit Special Products oversees the production of optical tracers. A class C cleanroom is available for the production of buffers and bulk optical tracer solution. Final sterile filtration and filling is performed in a class B cleanroom. All aseptic procedures are performed in class A laminar air flow hoods. In addition, all products and intermediates are subject to quality control by the pharmaceutical laboratory before release by the QP. The lab is GLP and ISO15189 certified, and is equipped with HPLC, GC, pH and osmolality measurement apparatus, a workstation to perform target affinity ELISA’s and all relevant Ph. Eur. required tests. Once testing is completed a report is written and submitted to the QP of the department, who releases a batch for use in clinical trials.

The unit Special Products also uses these facilities for the pharmaceutical development of new tracers. During development, products which have undergone initial testing in research labs are taken in and reviewed, and a systematic review is performed to see if all critical process parameters have been defined. Tracers are then entered into formulation research and stability research, to generate data for the Investigatory Medicinal Product Dossier (IMPD). The IMPD and all associated documentation is maintained and kept up-to-date by the department of clinical pharmacy and pharmacology as required by GMP regulation.

Tracer

Bevacizumab-800CW is the first optical tracer produced by the department of Clinical Pharmacy and Pharmacology. It consists of the monoclonal antibody bevacizumab (Avastin, Roche Pharma AG) conjugated to the near-infrared fluorescent dye IRDye 800CW (LI-COR). The product was initially tested in the research lab of the department of medical oncology, and has undergone formulation and stability studies to make it into a pharmacy product fit for human use. The product can be produced in sufficient supply for multiple clinical trials and is stable when stored as a solution in the refrigerator for 12 months after production. The product is presented as a sterile injection vial containing 6mg = 6ml of tracer product.

Read the full-tekst published paper about bevacizumab-800CW here