Family Bank: Sevibe FamiCord

About

Sevibe Cells is a Spanish family cord blood and cord tissue bank of the FamiCord Group — 3^rd biggest cord blood bank in the world and biggest cord blood bank in Europe. FamiCord Group have also the biggest inventory of stored cord blood in Europe.

Since 2015, Sevibe has been the first cord blood bank in Spain accredited by AABB, demonstrating compliance with the highest international quality standards for cord blood banking. The laboratory is also certified according to ISO 9001:2015 quality management standards. Sevibe provides the collection, processing and long-term cryopreservation of umbilical cord blood and cord tissue for families in Spain and is committed to delivering safe, high-quality stem cell banking services.

Labs and Locations

Sevibe operates its own state-of-the-art laboratory in Parc Científic i Tecnològic de Girona (near Barcelona), Spain, where umbilical cord blood and cord tissue samples are processed and cryopreserved under strict quality and safety standards. The laboratories are designed exclusively for the processing and long-term storage of newborn stem cells for potential future therapeutic use by the child or compatible family members, in accordance with applicable regulations.

All sample processing is carried out in controlled clean-room environments to ensure maximum sterility and minimize the risk of contamination. Laboratory access is strictly controlled, and all critical systems are continuously monitored 24 hours a day, 365 days a year. The facilities are equipped with continuous temperature monitoring, alarm systems, fire detection, and backup power supplies to guarantee the integrity and safety of all stored biological samples.

Sample processing and cryopreservation are performed by highly qualified professionals following validated procedures and international quality standards. Sevibe is committed to providing families with the highest levels of quality, safety, and traceability throughout the entire banking process.

Business Experience

Sevibe is the leading Spanish family cord blood and cord tissue bank of the FamiCord Group, providing families with collection, processing, and long-term cryopreservation services in Spain. Sevibe has business headquarters located in Madrid, but Sevibe operates its own laboratory in GIrona outside Barcelona, ensuring full control over sample processing, storage, and quality management throughout the entire banking process.

Since 2015, Sevibe has been the first cord blood bank in Spain accredited by AABB, reflecting its commitment to the highest international quality standards. The laboratory also operates under certified quality management systems and comply with all applicable Spanish and European regulations governing the processing and storage of human cells and tissues.

Sevibe works closely with maternity hospitals, obstetricians, midwives, and healthcare professionals across Spain, offering families a comprehensive service that includes 24/7 collection logistics, laboratory processing, long-term cryogenic storage, and ongoing customer support. The company is committed to delivering safe, reliable, and high-quality stem cell banking services while promoting awareness of the current and future therapeutic potential of newborn stem cells.

FamiCord Group (operating under the name FamiCord AG since 2025, following the merger of PBKM and Vita 34 in 2021) is the European market leader and the third-largest stem cell bank worldwide. The Group has secured over 1.5 million biological material samples (mostly cord blood, cord tissue, placental blood, placenta). FamiCord has a robust operational infrastructure: 13 processing and storage laboratories, 2 storage only laboratories, and 3 cell & gene GMP centers for CDMO activity, controlling approximately 55-60% of the European cord blood banking market.

Supplying stem cells for medical use remains at the core of the Group's focus. FamiCord actively supports the use of stem cells in treatments, with a history of over 8,500 patients treated with 16,500 stem cell preparations including 278 cord blood applications (as of June 2026). The Group has been involved in several clinical trials in the area of: cardiology, neurology, dermatology, orthopedics and others in the role of sole sponsor, co-sponsor or supplier of cell-based ATMP. FamiCord also actively participates in cerebral palsy treatment programs for children [Expanded Access Program conducted in Lublin, Poland].

The CDMO (Contract Development and Manufacturing Organization) activity, primarily under the Bramble Bio brand, remains an advanced technological pillar. Through 3 specialized CDMO centers located in Germany, Poland and Portugal, the Group provides comprehensive manufacturing services for Advanced Therapy Medicinal Products (ATMPs) in compliance with cGMP standards, strengthening its position as a trusted contract manufacturer for the biotechnology industry.

Regarding the development of CAR-T cell therapies (oncology), the Group has revised its strategy. FamiCordTx, initially developed as an internal venture, is now an independent entity with which FamiCord Group is affiliated (holding an approximately 20% stake). This allows the Group to focus its resources on its core business and commercial B2B services.

The scale of medical operations is built on solid financial foundations. In 2025, FamiCord Group generated sales revenues of EUR 88.17 million (a 7.3% year-over-year increase) with significant proportion of recurrent revenue. The Group achieved an EBITDA of EUR 10.6 million (a 12.3% y/y increase). FamiCord AG is listed at Deutsche Boerse in Franfurt and is backed mostly by financial shareholders (AOC – private equity, SVF – investment fund, Nationale Netherlanden – pension fund and others). This guarantees absolute stability and security for the long-term storage of materials entrusted by patients.

Collection Kit

Sevibe's collection kit has been specifically designed to ensure the safe and efficient collection and transportation of umbilical cord blood and, where applicable, umbilical cord tissue. The kit contains all the sterile materials required for cord blood and cord tissue collection, maternal blood sampling, sample identification, and secure transportation to Sevibe's laboratories.

The collection kit is used within Sevibe's quality management system, which is accredited by the American Association of Blood Banks (AABB) and authorized by the Spanish Agency of Medicines and Medical Devices (AEMPS) for the collection, processing, cryopreservation, and storage of human cells and tissues. This ensures that every stage of the process is performed according to the highest international and national quality standards.

The kit is suitable for both vaginal deliveries and Caesarean sections and is designed to preserve sample integrity during transport to the laboratory. Each kit is individually prepared, fully traceable, and accompanied by clear instructions to facilitate safe and efficient collection by healthcare professionals.

Transportation container

The transportation container used by Sevibe has been designed to support the safe shipment of umbilical cord blood and, where applicable, umbilical cord tissue from the collection site to the laboratory. The container includes thermal insulation and/or validated gel packs to help maintain the required transport conditions and protect the biological material during transit.

The container has been validated under defined test conditions to maintain room temperature for a specified period of time, in accordance with AABB requirements. This validation is intended to preserve sample integrity and reduce the risk of temperature excursions during transportation.

The container also includes a temperature logger, allowing temperature conditions to be monitored throughout transport. This provides an additional level of traceability and quality control, supporting the safe reception and assessment of the sample upon arrival at the laboratory.

Shipping Info

Cord blood and cord tissue samples are collected directly from the birth hospital by Sevibe's designated medical couriers. Both the courier service and Sevibe's laboratories operate 24 hours a day, 365 days a year, including weekends and public holidays, ensuring that every sample is collected, transported, processed, and cryopreserved without delay. In accordance with Spanish and European regulations, all cord blood samples are transported to the laboratory and processed within 72 hours of collection. Shipping is included in the service throughout Spain.

Processing Method

Cord blood samples are processed manually using a validated sedimentation method with HES (hydroxyethyl starch). This method is used to facilitate the separation of the main cellular components of the sample, allowing the plasma to be separated from the stem cell-rich fraction and the red blood cells.

The objective of the processing method is to concentrate and preserve the relevant nucleated cell population, including hematopoietic stem and progenitor cells, while reducing unnecessary plasma and red cell content prior to cryopreservation. This helps optimise the final cellular product for long-term storage.

The process is performed by qualified laboratory personnel under controlled conditions and in accordance with internal quality management system validated by AABB and applicable standard operating procedures. Each sample is individually identified, processed and documented to ensure full traceability, consistency and compliance with the required quality standards

Components Stored

Sevibe stores the stem cell-rich fraction of umbilical cord blood in validated cryogenic storage bags designed for long-term preservation. Quality control segments are retained for future testing when required.

Upon completion of processing, families receive a storage certificate including key laboratory results, such as total nucleated cell (TNC) count, CD34+ stem cell count, cell viability, maternal blood screening results, blood group determination, and microbiological testing.

When requested, Sevibe also stores umbilical cord tissue for potential future regenerative medicine applications. Additional quality control samples are retained in accordance with the laboratory's validated procedures and applicable regulations.

Storage Method

Following processing, a cryoprotective solution is added and each cord blood unit is cryopreserved using a computer-controlled rate freezing system to ensure optimal cell preservation. The samples are then stored in validated cryogenic storage bags in the vapor phase of cryogenic nitrogen at temperatures close to -196°C, minimizing the risk of cross-contamination while preserving long-term cell viability.

All samples are uniquely identified using barcode technology and recorded in a secure database, ensuring complete traceability and rapid retrieval whenever required. Storage tanks are continuously monitored 24 hours a day, 365 days a year, with automated alarm systems that immediately detect and report any deviation from validated storage conditions.

Licensing & Accreditation

• Sevibe operates under the authorization of the Spanish Agency of Medicines and Medical Devices (AEMPS) in accordance with Spanish and European regulations governing the collection, processing, cryopreservation, and storage of human cells and tissues.
• Sevibe was the first cord blood bank in Spain to receive AABB accreditation, demonstrating compliance with the highest international standards for quality and safety in cord blood banking.
• Sevibe laboratories also operate under certified quality management systems in accordance with internationally recognized ISO standards.
• These accreditations and authorizations ensure that all laboratory procedures, quality controls, and storage processes meet rigorous national and international regulatory requirements.

Clinical Experience

As a Spanish member of the FamiCord Group, Sevibe offers families access to one of the world's leading stem cell banking networks. All samples are processed and stored under the same validated quality standards and clinical procedures applied across the Group, ensuring their availability for future therapeutic use when required.

• FamiCord Group has provided more than 8,500 clinical stem cell therapies worldwide, including both standard hematopoietic stem cell transplantations and experimental/regenerative medicine therapies.
• Famicord Group has released 278 cord blood units for therapy as of June 2026.
• The Group has extensive experience in releasing autologous cord blood units for children diagnosed with neurological disorders, particularly autism spectrum disorder (ASD) and cerebral palsy (CP), under dedicated therapeutic access programs.
• Selected laboratories within the FamiCord network also participate in public cord blood banking programs and collect cord blood donations intended for unrelated donor transplantations.
• FamiCord Group actively participates in clinical trials, observational studies, and compassionate use programs involving cord blood and mesenchymal stem cell therapies in neurological, hematological, immunological, and regenerative medicine indications. More information: https://famicord.com/science-and-clinical-trials/
• Through its GMP-certified manufacturing facilities in Poland and Portugal, FamiCord develops and manufactures advanced therapy medicinal products (ATMPs) based on cord blood, perinatal tissues, and mesenchymal stem cells. The Group is involved in translational medicine projects focused on developing innovative regenerative therapies and cell-based medicinal products.
• FamiCord collaborates with leading hospitals, transplantation centers, and regenerative medicine clinics across Europe and internationally, supporting innovative therapeutic programs using cord blood and perinatal stem cells.

Insurance

Sevibe operates under comprehensive quality and risk management procedures to ensure the long-term safety and integrity of all stored samples.

• The laboratories are protected by continuous security and monitoring systems 24 hours a day, 365 days a year, and operate according to validated business continuity and disaster recovery plans.
• If a cord blood sample does not meet the laboratory's quality acceptance criteria, no processing fee is charged and the sample is not stored.
• If the stored cord blood is required for a hematopoietic stem cell transplant according to established medical indications, Sevibe provides financial support of up to €20,000 to help cover the treatment costs, in accordance with the terms and conditions of its Treatment Protection Plan.

Community Service

Free banking may be offered to families where an immediate relative has a medical diagnosis for which stem cell transplantation is considered a standard therapy.

In addition, Sevibe may apply specific discounts for returning families who have previously stored biological material with the company, as well as for certain groups or collectives. These may include insurance companies, large corporations or other organisations with which Sevibe maintains specific agreements, where cord blood and/or cord tissue banking services are offered as part of an employee or member benefit programme.

Prices

Sevibe offers flexible payment plans to make stem cell banking more accessible for families. Special pricing is available through selected health insurance providers and partner healthcare institutions. Additional discounts may apply for twin pregnancies and other special family programs.

Additional Services

In addition to cord blood banking, Sevibe offers:

• Isolation and expansion of mesenchymal stromal cells (MSC) from umbilical cord tissue.
• Comprehensive portfolio of genetic testing services, including non-invasive prenatal screening (NIPS) during pregnancy,and newborn genetic screening, helping families gain valuable health information through advanced genomic analysis.