TIP
New Facilities for Gene and Cell Therapy Development Officially Approved for Use
Following a year long reconstruction, Masaryk University has officially received final approval for Pavilion C03 of the Faculty of Medicine, which will provide new GMP facilities for the future development of gene and cell therapies within the CREATIC Centre of Excellence.
In December, the reconstructed Pavilion C03 at the Masaryk University campus in Bohunice, one of the Faculty of Medicine’s buildings, was formally approved for use. For the CREATIC Centre of Excellence, this marks a major milestone, as the pavilion will become a key hub for the research, development and preparation of gene and cell therapies for patients with rare diseases.
The production and development area covers 1,000 square metres and has been designed as GMP cleanroom facilities meeting the most stringent international standards for advanced therapies. Because gene and cell therapies involve living biological material, often including patients’ own cells, the environment, technologies and related processes must be set up to ensure long term safety, consistent quality and full traceability.
The reconstruction took 12 months and resulted in significantly expanded capacity, including six cleanroom production units, modern technological equipment and strengthened technical infrastructure. Following the final approval, finishing works and relocation are now underway. These will be followed by the specialist phase of commissioning the facility for GMP operation and validating the cleanrooms, which is planned for the spring months. Once this phase has been successfully completed, the pavilion will be ready for manufacturing related activities, which are also subject to supervision and inspection by the Czech State Institute for Drug Control.
The reconstruction was carried out by a consortium of companies OHLA ŽS, EP Rožnov and IDPS. Despite the demanding conditions and challenges typical of reconstruction projects, the consortium succeeded in delivering the work on schedule.
The reconstruction of the pavilion has been funded from several sources. The main part is financed through the Jan Amos Komenský Operational Programme under the CREATIC Investment project (CZ.02.01.01/00/22_001/0000254), in the total amount of CZK 213 million excluding VAT. Additional funding was provided through the National Recovery Plan project (LX22NPO5102) and the Exceles programme of the National Institute for Cancer Research, in the total amount of CZK 12.7 million excluding VAT. Part of the reconstruction was also covered from the Faculty of Medicine’s own resources, amounting to CZK 36.8 million excluding VAT.
