Production and Quality Control

IHBT holds a certificate of Good Manufacturing Practice (GMP) for the manufacture and control of investigational medicinal products for advanced and gene therapy, valid for the whole EU. Current technical capabilities for the manufacture of investigational products include:

• Aseptic production in A/B cleanrooms for the manufacture of advanced therapy medicinal products.
• A/C production site for solution preparation and placement of closed systems.
• A GMO II isolator in class A/C for the production of gene therapy medicinal products.
• ClinMACS Prodigy® robotic closed system
• Controlled freezing and storage of cryopreserved product in nitrogen vapour
• Validated alternative sterility tests BACTEC and HB&L

Separate laboratories have been set up for quality control of modern therapeutic medicines, the operation of which is part of the GMP certificate:

• Functional Tests Laboratory - performs cytotoxicity tests and analyses by ddPCR in GMP mode.
• Flow cytometry laboratory - under the leadership of Assoc. Iuri Marinov has established simultaneous ISO 15189 and GMP operation.

If you are interested in cooperation, please contact the Head of the SVP Department for LP, Petr Lesny, M.D., Ph.D., MHA