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Family Bank: Biovault Family
Biovault is the UK's largest private human tissue bank and is licensed to handle all human tissue types. Biovault has been operating since 2002 and is the only private laboratory in the UK that works for the NHS to process and store cord blood and tissue, peripheral blood, and bone marrow stem cells. Biovault has provided over 4000 transplants of human tissue samples of various types to patients.
Labs and Locations
Location of the Biovault Human Tissue Bank laboratory:
Plymouth International Medical and Technology Park,
Biovault Family and Biovault Technical are part of the Biovault Scientific Group. Biovault is the UK's largest private human tissue bank and is licensed to handle all human tissue types including cord blood and tissue. Biovault was set up in 2002 to serve public and private health sectors looking to outsource the processing and storage of human tissue to an accredited and experienced expert.
- Biovault provides tissue banking services for a wide variety of public and private organizations worldwide, including services for the UK National Health Service (NHS).
- It processes and stores cord blood and tissue in partnership with the NHS.
- It is the processing and storage centre for the UK NHS South West Peninsula Transplant Service for peripheral blood and bone marrow stem cells.
- Biovault is the only private tissue bank that works with the NHS and the private sector.
- Biovault is also the contract lab used by several private cord blood banks in the UK and internationally.
Biovault is registered as a manufacturer of Medical Devices, which allows them to register their cord stem cell collection kits on the European market under the company’s ISO 13485 Accreditation. The kit allows for gravity collection into a cord blood bag that contains CPD anti-coagulant. The collection kit provides all consumables for the collection of the cord blood and cord tissue as well as the maternal blood sample for the required blood tests. The kit contains chlorhexidine swabs for disinfecting the umbilical cord before collecting the cord blood to reduce contamination of the blood. The collection kit is sterile both inside and out so that it can enter the operating room and be used during a C-section.
The Biovault transportation box has heavy duty gel packs designed to keep the blood up to 72 hours within the prescribed temperature range. It also has a specialized thermal insulation system that has been fully validated to maintain ambient temperature under test conditions. It has been audited by their couriers for shipping human tissue and cells worldwide. The transportation box complies with UN3373 and has been fully tested and accredited by an external body for compliance with IATA PI650.
The Biovault contract price includes shipping, both within their home country and at no extra cost from outside. Biovault has a dedicated customer care team available who will arrange the collection of the sample from the hospital to its facility using a dedicated courier service.
Biovault processes all human samples in clean rooms, and performs both microbiology tests as well as viability tests and stem cell counts (via CD34+ assay). Important aspects of Biovault's stem cell recovery process are automated, but trained technicians are responsible for separating stem cells based on the volume reduction method pioneered by Dr. Pablo Rubinstein at the NY Blood Center. Because of its unique processes, Biovault has been able to validate their stem cell recovery rate as above 95%.
After red cells and plasma have been removed, the final storage is the "buffy coat" layer of blood that holds both white cells and stem cells. Small testing portions are also stored in case they are needed for tissue typing or other diagnostic tests. Parents are provided with a certificate describing all test results, including CD 34+ cell counts & cell viability.
Biovault's final storage is in blood bags with two separate compartments in 20/80 ratio. The blood bags are encased in a cassette, both of which are bar code labeled, and the canister is security sealed. The unit is immersed in a freezer holding the vapour phase of cryogenic nitrogen.
Licensing & Accreditation
The Human Tissue Authority (HTA) is the accrediting body in the UK: Only tissue banks accredited by the HTA will be allowed to supply tissues for transplant at NHS hospitals. Biovault holds an open ended (no expiry), unconditional HTA License 11063 covering every aspect of all tissues for human transplant. Biovault has maintained their unconditional HTA status after multiple inspections, the last in March 2012.
Biovault is the only private tissue bank in the UK to be JACIE accredited since Nov. 2011, as it is the processing and storage centre for the UK NHS South West Peninsula Transplant Service for peripheral blood and bone marrow stem cells.
The BioVault laboratory...
- holds an open ended, unconditional HTA licence (no: 11063) which covers every aspect of all transplantable material for human application;
- operates in accordance with GMP procedures (international Good Manufacturing Practice protocol) drawn up by the W.H.O (World Health Organisation);
- is accredited by JACIE (Joint Accreditation Committee - ISCT - EBMT);
- is accredited by AABB (formerly the American Association of Blood Banks);
- is certified as Grade A, in a BL3 clean room (an environment that eliminates the introduction, generation and keeping of aero-transported particles, comprising 3 concentric areas with positive atmospheric exit pressure)
- is authorized to treat samples affected by some bacterial infections that can be cured by treatment, in quarantine
- has been accredited by the American National Standards Institute Regulatory Accrediting Body
- has been accredited by the Advancing Transfusion and Cellular Therapies Worldwide
- its organization's internal Quality Management is ISO 9001:2008 certified, (certificate no: GB04/62552)
- its Quality management standards for medical devices is ISO13485 certified (certificate no: GB07/72849)
- its flow Cytometers are externally quality controlled by NEQAS.
Biovault has stored over 25,000 cord blood collections from more than 10 countries as of January 2015. Biovault has released 10 cord blood transplants on behalf of private clients, 3 of them for autologous use by the donor baby. Biovault has additional clinical experience preparing bone marrow and peripheral blood stem cells for transplant by both the NHS and private clinics. Biovault has released over 4,000 peripheral blood and bone marrow stem cell transplants, all with a 100% success record (as of January 2015).
Biovault security precautions:
- The Biovault laboratory is protected by a 24/7 security system.
- All essential equipment have data loggers and are monitored 24/7.
- Storage fees that are paid in advance are held in an escrow account.
- Biovault has a disaster recovery plan in place which allows all of their cryopreservation tanks to be relocated to another HTA facility until theirs is back to normal.
Biovault offers their clients cord blood insurance for therapy via CellPlan
Family: Cord Blood Service
- Administration and Kit fee - £160
- Cord blood processing with 25 years storage - £1740 (total £1900)
Family Plus: Cord Blood and Cord Tissue Service
- Administration and kit fee - £160
- Cord Blood and Cord Tissue processing with 25 years storage - £2190 (total £2350)
Private phlebotomist (if required): £250-£330 depending on geographic location.
Prices are different in other countries, depending on the country of birth. Please contact Biovault for further information.
Biovault processes cord tissue by cutting the cord into fine pieces. The pieces are combined with cryoprotectant solution, placed in a bar code labelled bag in a canister, and cooled together with the cord blood sample in a controlled rate freezer. Biovault has validated this process and demonstrated viable cells post thaw. The procedure has been submitted to the HTA for approval.