MARROW BANK™

Collection, processing, and “long-term” cryopreservation of bone marrow mononuclear cells.

The procedure consists:

Collection:

Bone Marrow sample (80 c.c) is collected only once by trained personnel. The blood is collected with one or two syringes that contain the appropriate amount of anticoagulant and are packaged inside the appropriate collection kit under hip local anaesthesia.The ΚΙΤ is marked with a unique ...

Bone Marrow sample (80 c.c) is collected only once by trained personnel. The blood is collected with one or two syringes that contain the appropriate amount of anticoagulant and are packaged inside the appropriate collection kit under hip local anaesthesia.The ΚΙΤ is marked with a unique barcode, so that a continuous traceability exists and includes all the relevant documents that must be filled by the donor. The collection KIT is transferred immediately to the laboratories of Biogenea Pharmaceuticals Ltd for further processing.

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Processing:

Immediately after the arrival of the collection KIT at the laboratories of the company, it is unpacked and processed in a sterile environment under GMP conditions. The whole process is carried out directly with validated protocols according to the international regulations and specifications. ...

Immediately after the arrival of the collection KIT at the laboratories of the company, it is unpacked and processed in a sterile environment under GMP conditions. The whole process is carried out directly with validated protocols according to the international regulations and specifications. The final product can either be administered immediately after ex-vivo cell expansion bioreactors or can be frozen and cryopreserved for future use.

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Quality Control:

Each and every processing step is fully monitored. A small quantity from each sample is analyzed in an automated blood analyzer. Finally, Flow Cytometry is used to determine the final concentration of the total nucleated cells, the hematopoietic stem cells (CD45+/CD34+) and the cell viability ...

Each and every processing step is fully monitored. A small quantity from each sample is analyzed in an automated blood analyzer. Finally, Flow Cytometry is used to determine the final concentration of the total nucleated cells, the hematopoietic stem cells (CD45+/CD34+) and the cell viability of the final product. An inconsiderable amount of the preserved final product is stored extra and thawed after a couple of days in order to control the viability of the corresponding cryopreserved sample.Fully automated system has the advantage that its protocols are validated and the produced results are controlled and reproducible. Each collected sample undergoes full microbiological and genetic control. The microbiological control includes liquid culture in aerobic and anaerobic conditions using the automatic system. When a contamination is found in a sample, identification follows through an antibiogram. RealTime PCR is used to verify and identify the pathogen that is possibly detected in the serum of the sample.

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Long term Cryopreservation & Product Release:

Only after the completion of all the quality tests isolated Hematopoietic stem cells are stored in temperatures reaching the -196C ( in these conditions all the metabolic procedures are stopped ) and document/certificate of cryopreservation is issued.

What can you do with it:

Because of patented technology for the ex vivo hematopoietic stem cell expansion up to Total Nucleated Cells (x100 folds) and CD45+dimCD34+ hematopoietic stem cells (x10 folds). As a result, the isolated hematopoetic stem cells could be expanded in case of a future therapeutic use. They can be ...

Because of patented technology for the ex vivo hematopoietic stem cell expansion up to Total Nucleated Cells (x100 folds) and CD45+dimCD34+ hematopoietic stem cells (x10 folds). As a result, the isolated hematopoetic stem cells could be expanded in case of a future therapeutic use. They can be used as a therapeutical support for more than 70 hematological pathologies, such as: acute and chronic leukemia, myelodysplastic syndrome, aplastic anaimia, disorders of bone marrow and lymph, multiple myeloma etc.

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