GMP facilities at the institute’s Hannover site
To enable patient-specific dilution and aseptic fill and finish of investigational medicinal products (liquid dosage forms) in spatial proximity to the clinical departments, an appropriate GMP facility was successfully established at Fraunhofer ITEM in Hannover a few years ago. Furthermore, the possibility to manufacture ozone according to GMP for use as a challenge substance in clinical inhalation trials has been established and confirmed by the competent authorities. A corresponding GMP manufacturing authorization was granted by the competent authorities, but is dormant for the time being. The service unit “Quality Assurance” ensures that the regulatory conditions for resuming manufacturing operations, whenever needed, are met.
GMP facilities at the institute’s Braunschweig site
The Division of Pharmaceutical Biotechnology in Braunschweig has comprehensive expertise and a long track record in the development of GMP manufacturing processes for biopharmaceuticals. For this purpose, the division has established a GMP quality assurance system to ensure compliance with the German Drug Act, the German Ordinance on the Manufacturing of Medicinal Products and Active Ingredients (AMWHV), and the European Union GMP Guidelines. Other guidelines are also taken into account, e.g. those of the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use).
The division operates clean rooms of grades D to B according to Annex 1 of the EU GMP Guide, subdivided into different zones satisfying the respective hygiene and pressure requirements. Steam and water quality meets the requirements of the European Pharmacopoeia. All critical equipment for the manufacture of medicinal products has been qualified in compliance with Annex 15 of the EU GMP Guidelines. An automated filling machine enclosed in a restricted-access barrier system (RABS) of clean-room grade A in a clean-room grade B environment is available for manufacturing of small batches of sterile investigational medicinal products (IMPs) for use, for example, in clinical trials or stability testing.
The division has been repeatedly inspected by local and national authorities – the most recent inspection was successfully completed in March 2018 – and holds a manufacturing and importation license for microbial or animal cell culture biopharmaceutical APIs and for IMPs.
Biopharmaceutical products can thus be developed in collaboration with industrial and academic partners and can consistently be manufactured to the required quality – from initial cell line development and manufacturing of master cell banks to the optimization of production steps and the released IMP.