Accredited Services Based on International Quality and Safety Standards

Lifeline is an international bank close to home. Lifeline’s Cellular Therapy Products laboratory bears accreditation from TWO internationally acclaimed bodies which cover all the necessary clinical tests for the suitability of the units for storage. We are committed to offering quality cellular therapy services of the highest professional standards, with respect to the parents that have entrusted us with their children’s stem cells for a healthier future.

 

Traceability

Upon receiving the biological samples, the identity of the donor and parents is verified. All data is kept in the donor’s file, which will be constantly updated with data from all the procedures that will follow.

 

Cord Blood Stem Cells Separation

The cell separation procedures are performed under strict sterile conditions in a closed system. Cells are separated or isolated from the biological units we receive, using the latest technology which is the first automated method for the separation of heamotopoietic stem cells to conform with the strict European Union and FDA standards, the Biosafe Sepax 2 technology.  The cost of the Biosafe Sepax 2 method is significantly higher compared to traditional manual methods of cell separation, yet, it offers additional safety and superior product quality. Already more than 11 thousand units processed worldwide by this method, have been successfully transplanted to patients.

 

Cryopreservation 

Separation is followed by the airtight sealing of the blood in a double compartment cryobag which is then placed in a predefined slot in liquid nitrogen banks for long term storage. Lifeline cryopreserves all units in a 3rd generation cryobanks, the MVE High Efficiency/Vapour Series, where all units are preserved in Liquid Nitrogen vapour at -196oC rather than immersed in liquid. This allows temperature stability, especially during accessing the banks for the deposition of additional new units.  Temperature readings are recorded electronically at 15 minute intervals for quality control purposes and this data forms part of every unit’s records.

 

Accredited Methods for the Testing of Cord Blood and Tissue

Lifeline’s Cellular Therapy Products laboratory bears accreditation from TWO international acclaimed bodies which cover all the necessary clinical tests for the suitability of the units. Furthermore, Nucleic Acid Testing with the method of PCR is performed for HIV (AIDS), Hepatitis B and Hepatitis C is conducted by an authorized and licensed Reference Laboratory.

 

Independent External Quality Control Monitoring

All laboratory procedures are regularly monitored by the UKNEQAS (United Kingdom National External Quality Assessment Service) as well as the Finnish organisation LabQuality to assess their accuracy.

 

Quality Management System

Lifeline’s accredited Quality Management System determines the minimum quality and safety eligibility criteria for the banking of blood units. Therefore, a number of units may be rejected and not banked if they do not meet these criteria. However, successful banking does not necessarily guarantee future use; transplant centers will evaluate each available unit prior to use and the decision for using a blood unit will depend on several parameters, including, the compatibility with the patient, the nature of the disease, the weight of the patient and the number of cells it contains. The AABB Accreditation offers the quality assurance as an additional parameter that facilitates the transplant specialists in their decision regarding the use of cord blood in medical applications.