Lifeline offers its clients a highly scientific service with great emphasis on quality. This service covers administrative, scientific and financial procedures as following:
- Client Enrolment and registration to the service
- Collection of umbilical cord blood and tissue units
- Transportation and shipment of units
- Reception and evaluation of units at our laboratories
- Processing, testing and cryopreservation
- Long term storage
- Accounting and financial settlement
- Issuing of cellular therapy products for human application
All the above procedures are documented in detail and form Lifelines’ Quality Management System.
It complies with:
- European Union Legislation deriving from the relevant EU directives
- The AABB Cellular Therapy Products Standards
- The International Standard ISO: 15189 Medical Laboratories-Particular requirements for quality and competence.
- International Standards Organization: Proficiency testing by interlaboratory comparisons - Part 1: Development and operation of proficiency testing schemes [Guide 43-1] and Proficiency testing by interlaboratory comparisons - Part 2: Selection and use of proficiency testing schemes by laboratory[Guide 43-2]
Lifelines QMS ensures that:
- Lifeline meets all legal requirements
- Lifeline meets all accreditation standards
- Sufficient resources and management time is devoted
- Internal and external quality control assessments are performed regularly
- Any deviations or non-conformities to the system are identified and dealt with timely and appropriately
- Lifeline has obtained approval, licensure and accreditation as a tissue establishment for the donation, procurement, testing, processing, storage, distribution and import of cord blood and cord tissue by the Ministry of Health as directed by the Rep. of Cyprus Legislation, Law 187(I) 2007. (Click here for the Certificate)
- Lifeline’s Cellular Therapy Laboratory bears a CYS: EN: ISO 15189:2012 Accreditation for all tested fields performed to serve the purposes of cell and tissue testing and cryopreservation.
- Lifeline’s operations concerning the cord blood services are accredited by the AABB organization based on the AABB International Standards for the Cellular Therapy Product Services
External Quality Control
Lifeline’s Cellular Therapy Laboratory participates in recognised External Quality Assessment Schemes and the results are subjected to strict internal and external quality controls. "External quality control checks" means that Lifeline, periodically up to 12 times a year receives unknown blood samples where we have to perform laboratory investigations and report our findings to the organizations that run the external quality control schemes. Based on our findings, we are assessed on the accuracy and efficiency of our laboratory and the investigations we employ.
The organisations that provide the external quality control schemes for Lifeline are:
- The UK National External Quality Assessment Service (UKNEQAS) which provides external quality control for serology testing, CD34+ Stem Cell Enumeration, Full Blood Count and ABO/Rh performance, and
- The LabQuality Service based in Finland which provides external quality control for microbiology blood culture techniques.
Code of Ethics
According to the Quality management system and the code of ethics signed by all members of staff, recruitment of clients is performed in an ethical way quoting acceptable scientific evidence documented and published in reputable media, scientific and medical journals and clearly discriminating between valid current uses of HPC, experimental therapies and possible future applications. It is their responsibility that prospective clients clearly and fully understand their 3 options available regarding CB Banking: Public Banking, Family Banking and discarding without banking.
Information package including brochure and website have been reviewed and approved by State authority according to legislation deriving from EU Directives regarding the standards of Quality and Safety of Human Tissues and Cells.
Thermally insulated material conforming to the IATA
and UN 3373 Regulations
suitable for the safe transportation of biological samples.
The inclusion of the icepack provided in a separate compartment of the kit allows for the simulation of a refrigerated environment maintaining temperatures between 4 and 26 ° C, which is the ideal environment for maximum cell viability.
Temperature continuously monitored with the inclusion of a data logger
Unique Life kit tracking code ensuring maximum traceability (preventing any loss or mix-ups)
Dedicated bag specially designed for cord blood collection
Bag contains 25ml of anticoagulant which is the ideal type and volume to achieve good separation of the blood components
Bag bears two sterile needles. This enables the doctor to attempt and obtain more blood at a different site on the cord if blood flow stops thus achieving efficient blood collection without the risk of contamination.
Specially designed needle caps that lock and secure thus preventing any accidental perforation of the bag during transportation.
Specially designed sampling port and connecting port to the processing SEPAX system maintaining a closed system throughout processing, thus preventing contamination.
Lifeline employs the Biosafe - Sepax methodology for the processing of umbilical cord blood. The unique qualities of each infant’s stem cells are well appreciated and every blood unit is processed individually, respecting its biologic specificity and cell characteristics.
In fact, Sepax is the only cord blood processing technology that takes care of one single unit at a time, which further ensures full traceability and eliminates the risk of accidental mixing-up of units.
Sepax is also the only fully automated available system for cord blood stem cell isolation that can claim to have processed over 2,000 cord blood units subsequently used in transplantation. Such a significant transplant outcome data is a clear indication of product efficiency and quality.
Biosafe - Sepax is an official Collaborator of the NetCord organization and is used by over 70% of NetCord cord blood banks. Sepax is used in the most stringent regulatory environments and complies with the highest industry quality standards, such as FACT and AABB.
Stem Cell enumeration and cell viability
Lifeline employs flow cytometry
analysis to accurately enumerate (count) the number of stem cells that each cord blood unit contains. Unlike unreliable manual methods employing microscopy, the method employed by Lifeline, not only excludes cells that do not carry stem cell characteristics but also excludes dead or apoptotic cells. Apoptotic cells appear as living cells, but have entered into a timed procedure that will lead to cell death.
Processing storage and eligibility for banking
Quality System dictates strict criteria for the eligibility of units for collection and banking;
Quality System ensures that units banked will have realistic minimum cell content that can be useful in medical treatments. Cryopreservation of cord blood units is performed in 3rd generation cryobanks that add an extra safety to the cryopreserved units. MVE High Efficiency/Vapour Series R-190
is designed for the user who needs low-temperature vapour storage, easy maintenance and low liquid nitrogen consumption. The offset neck and rotating tray design provides access to all stored products. Our efficient thermal design ensures 95% of system surface area enclosed by vacuum while maintaining the lowest sample temperature in the industry. (-190°C).
Specifically designed for vapor storage
No artificial aids for lowering and maintaining temperature as with competitive tanks
Liquid reservoir below sample platform will typically maintain temperature for more than 20 days in vapor use offering extra safety to Lifelines banked stem cell units
Validated to maintain temperature of samples for at least two hours with lid removed
Temperature measurement by RTD, the most accurate system available. Furthermore Lifeline employs additionally independent temperature monitoring system connected to remote alarms
All units are cryopreserved in double compartment cryobags allowing the detachment of a portion of blood for ex vivo expansion. Each unit is vacuum sealed in a special overwrap and each unit is enclosed in a metal canister for maximum safety.
Further to the cord blood collection and banking service that has been offered so far, Lifeline introduces an innovative new cord tissue banking service
. This service is the result of intensive scientific research and protocol design by Lifeline’s Research and Development department in close collaboration with British Educational Institutions and a reputable German Research and Biotech organisation.
Lifeline’s in-house protocol is based on the following principles:
Separate and cryopreserve the 2 types of stem cells found in the umbilical cord
Bank such stem cells in their purest form ready to be thawed and manipulated with the techniques of the future to produce a cellular therapy product for application at the time when it is needed
Apply minimum manipulation to these cells without the use of chemicals or enzymes maintaining their original character and potential
Avoid sub optimal cell culturing techniques which run the risk of changing the character of such cells and making them less effective in their future purpose
Avoid applying todays technology involving cell cultures aiming at the production of a cellular therapy product that will be used in the future; unmanipulated cells are cryopreserved ready for cell culturing/expansion techniques using future more efficient technology
Avoid culturing of cells in animal based growth media, thus eliminating the risk of any animal born infections such as Creutzfeld Jacob Disease (Mad cow disease)
Cryopreserve the 2 two different types of stem cells separately thus allowing the future transplant specialists to grow these cells in near pure cell cultures without the difficulties of mixed cultures and cell contamination
Cryopreserve individual cells rather than chopped or minced pieces of tissue thus achieving better cryopreservation and more viable cell numbers at thawing.
Lifeline offers two novel cellular therapy products as a single package: Cryopreserved Wharton’s Jelly Cells which are rich in Mesenchymal Stromal Progenitor cells and vascular tissue rich in Vascular Endothelial Progenitor Cells.
A quality management system (QMS) expresses the organizational structure, procedures, processes and resources needed to be implemented
- Organizational Structure
- Customer Satisfaction
- Continuous Improvement
Blood,urine, fluids and other specimens containing orsuspected of containing infectious substances must be shipped according to applicable government and International Air Transport Association (IATA) regulations.
Category B: Diagnostic specimens, assigned to UN 3373, are human or animal materials that are being transported only for the purpose of diagnosis or investigation. Such materials include excreta, blood and its components, as well as other tissues and fluids. Diagnostic specimens do not include live infected animals. Referred to as Biological Substance, Category B. It is classified by IATA as infectious substances which does not meet the criteria for inclusion in Category A. Does not cause permanent disability of life threatening or fatal disease to humans or animals when exposure occurs. Must be assigned to UN3373.