AboutBiovault is the UK's largest private human tissue bank and is licensed to handle all human tissue types. As of March 2012 Biovault Family offers expectant parents direct contracts for the services of cord blood and cord tissue processing and storage. Biovault has processed, stored and provided for transplantation over 2500 human tissue samples of various types.
Labs and LocationsLocation of the Biovault Human Tissue Bank laboratory:
Plymouth International Medical and Technology Park,
Biovault Family & Biovault Family Hong Kong are part of the Biovault Group. Biovault is the UK's largest private human tissue bank and is licensed to handle all human tissue types including Cord Blood.
• 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).
• 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. See the list of Biovault clients.
Collection KitBiovault is registered as a manufacturer of Medical Devices, which allows them to CE-mark their cord blood collection kits under the company’s ISO 13485 Accreditation. Biovault is the only tissue bank that has a CE marked cord blood collection kit. The kit provides for gravity collection into a Pall 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 chlorotip 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 so that it can enter the operating room and be used during a C-section.
Transportation ContainerThe 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 (not polystyrene) that has been fully validated to maintain ambient under test conditions.
Shipping Info:The Biovault contract price includes shipping, both within their home country and at no extra cost from outside. Biovault has a customer care team available who will arrange the collection of the sample from the hospital to its facility using a dedicated courier service.
Processing MethodBiovault 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 it unique processes, Biovault has been able to validated their stem cell recovery rate as above 95%.
Components StoredAfter 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.
Storage MethodBiovault'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 & AccreditationThe 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 transplantable material for human application. Biovault has maintained their unconditional HTA status after multiple inspections, the last in March 2012. Biovault holds additional accreditations including ISO 9001:2000 for internal quality management and ISO 13485 management standards for medical devices. Biovault is the only private tissue bank in the UK to be JACIE accredited, since Nov. 2011.
Clinical ExperienceBiovault has stored over 22,000 cord blood collections from more than 10 countries as of January 2012. Biovault has released 7 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 2,200 bone marrow stem cell transplants and 320 peripheral blood stem cell transplants, all with a 100% success record (as of January 2012).
- 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.
PricesBiovault Family (UK)
Cord Blood Service
· Administration and Kit fee - £160
· Cord blood processing with 25 years storage - £1340 (total £1500)
Cord Blood and Cord Tissue Service
· Administration and kit fee - £160
· Cord Blood and Cord Tissue processing with 25 years storage - £1730 (total £1890)
Private phlebotomist (if required): £250