BioVault ME

About

Biovault Middle East, under the leadership of Dr. Denise De Wiest, is a Dubai-based company that brings the services of the UK bank BioVault to the Middle East.  BioVault is the UK's largest human tissue bank, providing both public banking services for the National Health Service as well as private banking services to families.  BioVault holds an open ended, unconditional HTA license covering every aspect of all human tissue transplantation.

Labs and Locations

BioVault laboratory location:
Plymouth International Medical and Technology Park,
24 Brest Road, Derriford, Plymouth,
PL6 5XP,
United Kingdom

Business Experience

BioVault Human Tissue Bank is the UK's largest private human tissue bank and is licensed to handle all human tissue types including Cord Blood.  Since they were founded in 2002, BioVault has processed, stored and provided for transplantation over 2500 human tissue samples of various types. 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 contract lab used by several private cord blood banks in the UK and internationally.  See the list of BioVault clients.

Collection Kit

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 Container

The BioVault container 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 in the base price, both within the home country and at no extra cost from outside. The shipping service is provided by DHL, and is available on weekends and most holidays. Employees of the bank will make the shipping arrangements, check the paperwork, and dispatch a courier to pick up the cord blood from the hospital.

Processing Method

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 it unique processes, BioVault has been able to validated their stem cell recovery rate as above 95%.

Components Stored

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.

Storage Method

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 security sealed.  The unit is immersed in a freezer holding the vapor phase of cryogenic nitrogen.

Licensing & Accreditation

The Human Tissue Authority (HTA) is the gold standard of accreditation 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.  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 Experience

The BioVault laboratory has stored over 22,000 cord blood collections from more than 10 countries as of Sept. 2011.  BioVault has 6 cord blood transplants on behalf of private clients, 3 of them for autologous use (by the baby who banked).  BioVault has additional clinical experience preparing stem cells for transplant by the NHS, for whom they have released over 2,200 bone marrow stem cell transplants and 320 peripheral blood stem cell transplants, all with a 100% success record (as of Nov. 2011).

Insurance

  • The BioVault laboratory is protected by a 24/7 security system.
  • Storage fees that are paid in advance are held in an escrow account.
  • BioVault will pay the family a monetary amount in the event of a transplant or other stem cell therapy.
  • 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.

Community Service

BioVault provides discounts to medical doctors.

Prices

BioVault Mid East first year price is 3500 USD. 
The one-time fee covers 25 years of storage.
Payment plans are available upon request.

Additional Services

Optional services offered by BioVault:

  • Storage of umbilical cord tissue with umbilical cord blood.
  • Newborn genetic screening.
  • Storage of stem cells from adult bone marrow.

Prices with Additional Services

Storage of umbilical cord tissue with umbilical cord blood is covered by a one-time additional fee of 820 USD.