The “BioIndustrial Pilot Plant” at the Institute has been established as a semi-industrial facility for education, training and development of biotechnological processes.
In 2000 the Pilot Plant as a fermentation facility was adapted to full GMP compliance by Polymun Scientific, founded by Prof. Hermann Katinger. Until 2011 the Pilot Plant was continuously used under certain GMP regulations. With the relocation of Polymun Scientific to Klosterneuburg, the facility of 950 m2 with installation costs of approx. € 4 Million was delivered to the BOKU/DBT.
The implementation and adaptation for teaching, training and research activities was enabled by significant funding of the Federal Ministry of Education, Science and Research of the Republic of Austria (BMBWF) by the so-called MINT-initiative (federal initiative to strengthen education in technical disciplines). With this funding the infrastructure was modernized to provide technical equipment for profound teaching and practical courses for our students in semi-industrial scale and additional capacity for industrial trainings for the industry and start-ups.
In 2013 the existing facility with its infrastructure – bioreactors and media vessels for microbials and mammalian cell culture in the scale from 30 to 1600 L - was modernized by upgrading to an industrial standard process control system (Siemens PCS7) as well as modern process sensors and analyzers. This GAMP 5 conform process control system allows flexibility in different process operation, feed strategies, cultivation strategies, and the batch program is based on the ISA-88 standard with an integrated audit trail system.
In 2016 the facility was expanded by two cell culture bioreactors, 15 and 100 L culture volume, as part of a research project together with a European company specialized in civil and industrial construction, engineering and services.
For primary recovery and downstream processing, the facility is equipped with a high-pressure homogenizer, ultra-and dia-filtration system, chromatographic system and filtration systems in pilot scale.
Process analytics of biomolecules complete the Pilot Plant portfolio. There are various HPLC devices with different detectors for the analysis of peptides and proteins, amino acids, nucleotides, carbohydrates, membrane components, and degradation products available. Furthermore, methods and devices for particle size measurement, homogeneity and surface charge of nanoparticles, biophysical characterization of nanoparticles, interaction and kinetics of biological fluids and samples are in place.
Approx. 650 m2 of the entire facility with a total size of 950 m2 are located in a monitored class D clean room, special labs are class C.
The individual areas such as microbial fermentation, animal cell culture, downstream processing, inoculum preparation and filling as well as monitoring (both are class C clean rooms) are spatially separated from one another.
The plant has an independent water supply for high quality water, process air generation, pure steam generation and the inactivation of biological waste.
Maintaining of the facility, utilities and equipment is performed according to Standard Operation Procedures for cleaning and sanitization. Particle and microbial monitoring procedures are established for control purposes.
Safety at work and the well-being of our employees, trainees and project partners are particularly important to us, which is why we started the ISO 45001 certification for health and safety at work in 2020.