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GMP Cell Therapy Unit
Cell processing unit according to Good Manufacturing Practice (GMP)
General Facts
The GMP cell processing unit consists of four positive air-pressure modular clean-rooms covering a total surface of 35m2 inside the main building of the Medical School. The cell processing spaces include two rooms of different air-particles load levels per cubic meter in the size of 0,5μm, class 10000 and 1000 according to the Federal Standard FS209E or/and Grade C and B according to the European Guide to Good Manufacturing Practice (EU GGMP).
The unit uses an autonomous air-conditioning system and an air-conductors system for the best distribution of air in space and also for the desired humidity levels, suitable HEPA (high- efficiency particulate air) fan filter units for maintaining the predefined levels of air cleanness, specific epoxy self-leveling floor and an electronic-controlled access system. Furthermore, it is equipped with all the necessary state-of-the art equipment for cell culture and large-scale cell production e.g. laminar air flow biological safety cabinets, CO2 incubators, centrifuges, microscopes as well as a complete cell-cryopreservation system.
Prospects
The construction of the GMP cell processing facility has supported the establishment of a regional public Cord Blood Bank (CBB) for allogenic use in the Medical School of University of Crete under the auspices of the University Hospital of Heraklion and the corresponding Ministry of Health. In this context, an Information and Collection of Cord Blood Center has been established in the Medical School since September 2014 with the following activities:
a) steady informative seminars for the general public in order to disseminate the knowledge about the importance and benefits of Cord Blood (CB) donation.
b) reception of the CB units (CBUs) and umbilical cords on a daily basis from parents-donors.
c) initial examination of CBUs quality and forwarding of the appropriate CBUs to the closest public CBB (the Hellenic Cord Blood Bank in the Biomedical Research Foundation Academy of Athens) for further processing.
d) dispatching of the CBUs, that do not meet the criteria for clinical use in allogenic transplantations, for research purposes in the field of stem cells following donors’ consent.
Based on the infrastructure of the GMP cell processing facility and further funding programs, the regional public cord blood bank of Crete is ready for operation, supporting all cell processing and cryopreservation stages that will be received. To this end, the CBB of Crete in collaboration with the other two public CBBs of Greece can actively contribute to the treatment and therapy of patients with hematologic malignancies through the hemopoietic stem cells that can be disposed of for allogenic transplantation, harboring huge benefits not only for the community but for the entire country as well.
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| Genomics Lab |
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The award of the TransPOT grant has allowed us to acquire a state-of-the-art laser capture microdissection system and a robotic real-time PCR system for mid and high-throughput analyses. Trained personnel funded by TransPOT ensure the professional use of this equipment and aids users to optimize their experiments when using the facilities. |
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| GMP Cell Therapy Unit |
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The GMP cell processing unit consists of four positive air-pressure modular clean-rooms covering a total surface of 35m2 inside the main building of the Medical School. |
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