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GMP Facility of MU – Manufacturing of immunotherapy pharmaceuticals for clinical trials

  Detailed description:

Center name: GMP Facility of Masaryk University (MU), Brno, Czech Republik
Head: Roman Hajek, MD PhD, Professor of Oncology
Address: Kamenice 5, Brno 62500, Czech Republic

GMP facility enables preparation of pharmaceuticals in the laboratory conditions approved by the Czech State Institute for Drug Control. The laboratory holds Certificate of GMP Compliance of a Manufacturer since 2008.

Manufacturing license allows for cell culture-based production for clinical trials I,II,III in the area of Human Investigational Medicinal Products, including:
1. Manufacturing operations
1.1. Sterile Products
1.1.1.Aseptically prepared
1.1.1.4. Small volume liquids
1.1.1.5. Solids and surgical implant
1.3. Biological medicinal products
1.3.1.3. Cell therapy products
(autologous and allogeneic products based on in vitro cultivation of hematopoetic and non-hematopoetic stem cells, immunocompetent cells and its depletion).

Monitoring of the production process, as well as final safety and quality verification is provided by MU expert staff. Laboratory (120 sq.m.) consists of three independent production units, what divides laboratories into A to D classes.

Examples of products produced/ activities carried in the GMP MU facility:
- antitumor pharmaceutical - tumor infiltrating lymphocytes (TIL),
- dendritic cells-based vaccine,
- antitumor pharmaceutical for patients with glioblastoma,
- recultivation of tumor lineages.

  Contact person:

Roman Hajek, MD PhD
Phone: +420532232144
mob.: +420728854226
fax.: +240549498480

Masaryk University (MU)