All stages are performed in licensed and accredited facilities according to a very detailed Quality System employing Good Manufacturing Practices (GMP’s) Good Laboratory Practices according to the laws and the regulations of international accreditation bodies
Umbilical Cord Tissue Processing Stages
A section of the umbilical cord, 15-30cm long is delivered to Lifeline’s laboratories in a dedicated sterile-beaker that has been filled with sterile saline solution at the maternity room.
The cord section is received clamped at both ends covered by saline solution to maintain the cords integrity.
Upon receiving at the laboratory, traceability checks are performed to establish the source of the cord tissue and laboratory staff evaluates the suitability of the cord section for processing.
Under Good Manufacturing Practice (GMP) procedures in the clean room and under sterile conditions in HEPA filter Laminar flow cabinets, the cord tissue is segmented and the two types of tissue Wharton’s Jelly – that contains the Mesenchymal Stem Cells and the Endothelial Stem Cells (vein and arteries) are separated and processed independently.
Wharton’s jelly tissue is dissociated and brought to cellular level and is suspended in a solution of the donors own plasma or serum obtained during cord blood processing when available. The cell suspension is administered into a dedicated cryobag and cryopreserved in the same way as cord blood is cryopreserved with the addition of a cryoprotectant solution. Sections of the vein and arteries are also processed in a similar way and are cryopreserved separately.
Cord Blood Processing
Laboratory officer will be assigned for each unit. The Laboratory Officer shall evaluate, process, cryopreserve and store the unit according to written procedures.
Initial Evaluation of the cord blood unit received includes
Verification of donor data, ensuring that all details on the relevant forms are completed and the Life-Kit identification number matches the Life-Kit number given to the parents
Once full traceability is established, a receipt is issued.
The laboratory officer proceeds to the visual and physical inspection of the blood bag containing the infants cord blood
If all details are correct and the unit is approved for further processing the laboratory officer proceeds to the initial sampling
At this stage, the unique position in the cryobank is booked and allocated to the unit. Units that do not meet the minimum criteria or if traceability is compromised with missing information, then such units are rejected and discarded as clinical waste according to written SOPs
All units undergo volume reduction and red cell depletion, which means that the unwanted components of the blood are removed and discarded as waste products. Plasma or serum obtained as a waste product is used as a medium for the cryopreservation of the umbilical cord tissue cells if client choose this additional service.
The remaining blood rich in nucleated cells with their subpopulation of stem cells (haematopoietic stem cells, mesenchymal stromal and other types found in cord blood) are automatically transferred into the special cryobag that will hold the blood for the duration of the banking period.
The whole procedure is automated performed in specialized equipment specific for this operation. Lifeline uses the Biosafe Sepax equipment to perform this delicate procedure. Learn More
The procedure is performed in a closed system which eliminates the risk of contamination
Following volume reduction the cord blood unit (now termed buffy coat) is taken by the designated laboratory Officer to the Clean room for the addition of cryoprotectant – an approved, medical grade chemical mixture that enables the cells in the buffy coat to survive the extreme cold conditions that will follow.
This procedure is performed in dedicated Clean Room facilities whereby HEPA Class II filtered air is pumped in the room creating a positive pressure and preventing unfiltered air to enter the sterile room even with the doors opened.
The cryoprotectant, which is a solution of DMSO and Dextran (a type of sugar), is used routinely in the science of cryopreservation. It is particularly important in the freezing and long-term storage of hematopoietic stem cells because without it, up to 90 percent of frozen cells will become inactive.
Following the addition of the cryoprotectant, the cord blood unit is then inserted into a gradual rate freezing, process where cord blood units are frozen gradually thus ensuring maximum cell survival.
When the unit reaches the desired temperature it is then rapidly transferred by the dedicated laboratory officer to its permanent position in the liquid nitrogen banks.
Lifeline uses the MVE Chart liquid nitrogen banks which hold the inventory system containing cord blood units at temperatures between -180° and -196°C.
The temperatures of the banks are continuously monitored and recorded every few minutes and the temperature recording devices are connected to a remote alarm that will sign on in the unlikely event that the temperature rises above -170ºC.
According to international regulations, cord blood must be banked at temperatures below -150ºC.