The Unit Biotech & ATMP’s has been set-up for the development and GMP manufacturing of biologicals for phase I/II clinical trials. The unit is a new part of the Department of Hospital and Clinical Pharmacy of the UMCG.
The GMP facility is designed for the production of drug candidates developed by the UMCG as well as drug candidates developed by external parties. The 550 m2 unit has the facilities and infrastructure to develop and produce a diversity of products in small amounts and is as such a multi-purpose facility for (pre)clinical manufacturing. These products can vary from: cell banks, mammalian and bacterial recombinant proteins, vaccines, viral products and plasmid DNA. Moreover, a production room for Advanced Therapy Medicinal Products (ATMP’s) is available for the manufacture of cell- and gene therapy products and tissue engineered products. Manual filling of these products is also possible in the facility. The lay-out is such that all pharmaceutical (GMP) and containment (MLII or BSL2) standards are met in order to guarantee product and personnel safety. The policy is to use disposable products as much as possible during production.
In the research phase of a clinical project, the Unit Biotech & ATMP’s can give useful advice on GMP items in order to allow a short tech-transfer traject of the product to the GMP production phase. This can be on process development, validation and analytical assays.
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