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Family Bank: Sorgente+
Sorgente S.r.l. and their partner SmartBank Scientific S.r.l. offer services in Italy of Biovault Technical laboratory, the most highly accredited UK facility that provides cord blood and tissue storage for partners worldwide. Sorgente S.r.l. and SmartBank Scientific S.r.l.
Labs and Locations
Sorgente entrusts its client samples to Biovault Technical laboratory, the largest private human tissue processing and storage bank in the UK. Located in Plymouth, on the medical campus of Derriford Hospital, Europe's 4th largest teaching hospital, BioVault is the processing facility for the UK South West Peninsula Transplant Programme (which is the NHS). Blood testing of virology and microbiology is performed nearby at Derriford Hospital, which is CPA accredited.
Plymouth International Medical and Technology Park
24 Brest Road, Derriford, Plymouth, PL6 5XP,
Sorgente has staff answering telephones 365 days a year.
Sorgente+ provides a proprietary collection kit that includes:
- Supplies provided for gravity collection into a blood bag
- Sorgente+ proprietary blood bag
- Sterillium® for hand disinfection
- Type of anti-coagulant used: CPD
- The collection kit is sterile inside & outside for C-Section use
- Container includes gel packs for thermal stabilization
- Container is validated to maintain room temperature under test conditions
- Container is guaranteed to maintain room temperature for a certain number of hours
- Container includes a temperature logger
- Container meets IATA PI 650 criteria and is in accordance with EN ISO 2003 and to 93/42/EEC
- Shipping arrangements are made by Sorgente+
- Contract price includes shipping
- Standard shipping is by DHL Express (Italy) S.r.l
- The courier is available 24 hours a day, 365 days a year
- Employees of Sorgente+ pick up the blood from selected hospitals.
- Shipping is included in the base price within the home country.
The sample arrives in the Biovault laboratory and is processed on the same day. Laboratory processing is manual and based on the volume reduction methods described by world renowned stem cell scientist Dr. Rubenstein, methods currently quoted as achieving a stem cell recovery rate of >95%. The sample enters the BL3 clean room through a hermetic window with positive exit flow. Inside BL3, the sample is weighed, centrifuged, measured volumetrically, and undergoes microbiological tests, HLA tests, cytofluorimetric reading and any other tests required. The sample containing the cells is placed in the final PALL container or cryobag, and is mixed to 10% with DMSO. The cryobag is placed in a computerised temperature-reducing system. After the temperature has decreased, the cryobag is placed in a sealed metal container while small blood samples are separated for laboratory tests. The laboratory data is printed on the certificate of cryogenic storage signed by the Sorgente+ Scientific Director and duly authorized by the Laboratory Director.
- Parents are provided with a certificate describing all test results from cord blood and maternal blood (e.g. virus antibodies, cell counts, bacterial contamination, blood type).
- The final storage is a bag of frozen whole blood plus 5 testing samples.
The final storage is in PALL bags that are placed inside canisters. Specifically-separated subsamples are stored for any future tests required in case of transplant and/or treatment. In final storage, The stem cells are kept in the vapour phase of cryogenic nitrogen at -196°C. The temperature is controlled 24 hours a day, 7 days a week by staff and by automated systems.
Licensing & Accreditation
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 is an established member of the British Association of Tissue Banks and has recently become a member of the European, Middle Eastern and African Society for Biopreservation and Biobanking (ESBB), whose mission is to advance the field of biobanking in support of research relating to healthcare, education and the environment.
BioVault has 10 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 2,500 bone marrow and peripheral blood stem cell transplants, all with a 100% success record.
BioVault has Professional Indemnity insurance in place with Lloyds of London for 10,000,000 pound Sterling for any single event.
Sorgente+ offers newborn genetic screening for:
- Drug-induced hearing loss
- Lactose intolerance
- Deficiency of AAT (Alpha-1 antitrypsin)
- Gluten Intolerance
Other services offered by Sorgente are:
- Assicura terapia: guaranteed repayment of the costs when using cord blood, up to a maximum of 5,000 €.
- Opzione 25 anni: allows the extension of storage duration up to 25 years.
- Conservazione autologa - solidale (Autologous - supportive cryopreservation) which allow to the family to donate the cord in case of compatibility.