Family Bank: Secuvita Vita34

About

SECUVITA S.L. is the subsidiary in Spain of the German bank VITA 34 AG.  Founded in 1997, VITA 34 was the first private cord blood bank in Europe and has stored more than 230.000 stem cell deposits for families from Germany and 29 other countries. Moreover, stem cells stored at VITA 34 have been applied in medical therapies 51 times already – proof of the high quality of storage at VITA 34.

Labs and Locations

Vita 34 has two state-of-the-art laboratories in Germany which operate exclusively in line with the highest medical quality standards (GMP – Good Manufacturing Practice) and which are monitored by German authorities. The in-house quality assurance monitors the overall GMP compliance of the processes in the ultra-modern clean room laboratory and the storage in the cryo-tanks. This way, Vita 34 ensures quality and safety on the highest level for decades. The laboratory at Vita 34’s headquarter in Leipzig was the world’s first glass-enclosed laboratory and can be viewed on tours.

Business Experience

SECUVITA is part of the Asociación Española de Bancos de Células Madre (ABACELL).

Vita 34 has more than 25 years of experience in the field of stem cell banking and has more than 230.000 customers, of which more than 23.000 are Spanish babies. Stem cells from both subsidiaries and distribution partners are processed and stored centrally in Germany. 

The Vita 34 partner in each country is responsible for all steps and procedures until the samples are received at Vita 34. This includes marketing and distribution, the training of the hospital staff, all the communication with the customer as well as the transport of the cord blood and cord tissue samples to Vita 34. Together with its partners, Vita 34 works together with about 2.000 maternity institutions and more than 15.000 obstetricians.

When a stored sample is need for medical applications, Vita 34 undertakes all necessary prearrangements – from additional tests in the laboratory to the transportation of the cord blood to the hospital, up to the preparation for transplantation. Therefore Vita 34 has developed a tailor-made transplantation logistic and established – as a forerunner in Europe – the first mobile stem cell team. Thus, Vita 34 offers treatment while observing the highest standards of quality that are possible in any hospital. The 51 cord blood units released for transplants have met strict quality requirements to be released clinically.

In order to study the potential applications of UCB stem cells and to develop new cell products, Vita 34 is working together with renowned research institutes and universities, and actively participating in applied stem cell research.

Collection Kit

To ensure top quality, Vita 34 developed many tools itself in accordance with top standards: The Vita 34 collection bag for umbilical cord blood called “Entnahmeset Vita 34” has a special designed foil for better survival of blood cells during transportation as well as a back-eye needle with higher diameter to collect higher volumes of blood. Moreover, the collection set contains a lower CPD (anti-coagulant) quantity for higher survival of stem cells in samples with low volume. The collection bag is sterile both inside and outside so that it can be used in an operating room during C-section. The bag is validated and accepted by the Paul-Ehrlich-Institute (Federal Authority for Vaccines and Biomedicines in Germany).

Transportation container

The cord blood (and the cord tissue) are transported in a thermally insulated shipping box designed by Vita 34: The transportation box is validated and tested to maintain room temperature under test conditions.  In Germany transport temperature of 18-26° Celsius is mandatory. Therefore the box contains large gel packs to stabilize the temperature and a data logger to monitor shipping conditions. Vita 34 pioneered the use of temperature loggers in cord blood transport.

Shipping Info

For all shipping arrangements, Vita 34 or the distribution partner are responsible. All cord blood and cord tissue samples are transported, by courier, 365 days, all year round, including national and bank holidays, to the laboratory of Vita 34 in Leipzig, Germany.

Processing Method

Vita 34 is able to offer the storage of cord blood via 3 different processing methods: Vita 34 has the permission for the professional production of pharmaceuticals as whole blood, and as separated stem cells via either SEPAX or AXP processing equipment. The processing method depends on the respective country.

Components Stored

Once the cord blood is processed, the Vita 34 laboratory and quality control manager will confirm the suitability of the sample (including stem cells count and viability).

Reports: Parents are provided then with a storage Certificate detailing their unique identity code, name and date of birth of the mother as well as date and time of birth of the child. The parents/clients are also provided with all test results from cord blood and maternal blood (e.g. virus antibodies, cell counts, bacterial contamination, blood type).

Storage Method

The storage tanks used by Vita 34 are completely independent from electric power supply. They are thermo tanks made of stainless steel. They contain a reservoir of -180 °C cold liquid nitrogen on the bottom. The samples are stored in the vapour nitrogen layer above. The advantage of this storage method, in contrast to cooling with liquid nitrogen, is that any cross-contamination between cord blood units is impossible.

The final storage is in a cryo-bag developed by Vita 34. The bag has a very high break strength, is very cold-resistant, and thus ideal for long-term storage. Together with the cryo-bag, 5 small portions of 1 ml each (aliquots) are stored in vials for testing purposes. This allows taking only a single aliquot and running tests before a medical application. The main unit remains untouched. For perfect protection the cryo-bag and the vials are encased in a very stable metal freezing cassette.

Licensing & Accreditation

Vita 34 has all required state authorizations and certifications. Moreover Vita 34 is the only private umbilical cord blood bank in Europe that has permission from the German Federal Institute for Immunizations and Biomedical Pharmaceuticals (Paul Ehrlich Institute) for the production and distribution of autologous and allogenic preparations and that can offer the preparation of stem cells via 3 different processes.

Furthermore, Vita 34 is the only private stem cell bank in the German speaking countries that has a permit for the collection, processing, cryopreservation and storage of umbilical cord tissue. All preparations are produced in line with good manufacturing practice (GMP) and are of certified quality.

Vita 34 is FACT accredited and FDA registered.

Clinical Experience

Number of all Vita 34 cord blood collections released for therapy: 51

Insurance

Vita 34 was the first cord blood bank in the world to provide parents with bankruptcy insurance. This unique security is an integral part of the service. In case of an insolvency the insurance guarantees that the child’s stem cell preparation will be stored professionally until the 50^th birthday.

Community Service

Vita 34 has a loyalty program for client referrals.

Prices

Secutiva offers different services/products, including the collection, processing and conservation, depending on the time the parents are willing to store the sample. For more information, phone: +34 917 431 400 or Email  info@secuvita.es

Secuvita offers these packages for storage of cord blood + cord tissue:

• Classic: processing and conservation included the first year and, subsequently, an annual fee is paid during the years you want to keep the sample.
• Compac 25: processing and conservation for 25 years (no storage fees).
• Compac 50: processing and conservation for 50 years (no storage fees).

Additional Services

Secuvita also offers:

• Preservation of umbilical cord tissue as well as cord blood
• Genetic tests
• Metabolopathies test
• Non-invasive prenatal test