Manufacturing and quality control

ÚHKT is a holder of the Good Manufacturing Practice (GMP) certificate for the manufacture and control of investigated medicinal products of modern and gene therapy, valid throughout the EU. Current technical capabilities for the manufacture of investigated products include:

• Aseptic manufacturing in clean rooms A/B for the manufacture of medicinal products of modern therapy.
• Manufacturing site A/C for the preparation of solutions and placement of closed systems.
• GMO II isolator in class A/C for the manufacture of medicinal products of gene therapy.
• Robotized closed system ClinMACS Prodigy®
• Possibility of controlled freezing and storage of cryopreserved product in nitrogen vapor
• Validated alternative sterility tests BACTEC and HB&L

For quality control of medicinal products of modern therapy, separate laboratories have been established, whose operation is part of the GMP certificate:

• Functional testing laboratory – performs cytotoxicity tests and analyzes using ddPCR in GMP mode.
• Flow cytometry laboratory, which under the direction of doc. Iuri Marinov introduced parallel operation of ISO 15189 and GMP.

If you are interested in cooperation, please contact the head of the GMP Department for Medicinal Products, MUDr. Petr Lesný, Ph.D., MHA