Biogenis FamiCord

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About

Biogenis Banca de Celule Stem of Romania is in continuous operation since 2007. Licensed by Romania's National Transplant Authority since 2010, Biogenis is the Romanian member of FamiCord Group — Europe's #1 and the world's #3 largest stem cell bank group. Biogenis key figures as of 2026: 200+ Romanian patients treated with cord blood or stem cells; 58 samples released by Biogenis; 30,000 clients units stored, 18+ years of uninterrupted activity in Romania.

Biogenis collects and cryopreserves three types of biological material at birth:

Hematopoietic Stem Cells (HSC) from cord blood — used to treat 80+ oncological and hematological diseases;
Mesenchymal Stromal Cells (MSC) from umbilical cord tissue (Wharton's Jelly) — with regenerative and anti-inflammatory properties applied in neurology, orthopedics, and ophthalmology;
Placental tissue (Placenta Plus, available since October 2024).

All samples are stored exclusively as concentrated stem cells — not whole blood — and cryopreserved at −196°C in liquid nitrogen vapor with 24/7 monitoring.

Biogenis holds multiple Romanian firsts in cord blood banking: first to store stem cell concentrate in multiple vials for repeated use; first to extract, process and purify DNA at birth; first to offer genetic testing from urine rather than blood; only Romanian bank providing a dedicated Patient Navigator service; and only group with its own pharmaceutical ATMP manufacturing facilities in Europe. In 2025, FamiCord Group was named the Top Stem Cell Bank in Europe by Life Sciences Review Europe.

Labs and Locations

Biogenis owns and operates its own processing and cryogenic storage laboratory in Bucharest, Romania (Bd. Dimitrie Pompei, nr. 10A, Clădirea CONECT 1, Sector 2). The laboratory is accredited by Romania's National Transplant Authority and is part of the FamiCord Group's network of 15 laboratories across Europe.

Clients who choose Galaxy STEM packages have their samples processed at FamiCord's central laboratory in Poland — the largest specialized cord blood laboratory in Europe — or at the FamiCord Swiss facility (Galaxy Switzerland package).

Business Experience

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

Biogenis provides a sterile collection kit free of charge, delivered directly to the family's home before the expected birth date. The kit contains all materials required for gravity collection of cord blood into a sterile blood collection bag, as well as a separate compartment for a 10–15 cm umbilical cord segment for MSC collection. The collection bag and all kit components are sterile inside and outside, making the kit fully suitable for use in both vaginal deliveries and Caesarean sections (C-sections).

Transportation container

The transport container uses thermal insulation with gel packs to maintain appropriate temperature conditions during transit from the hospital to the Bucharest laboratory. The container is validated to maintain the required temperature range throughout the expected transport duration. A temperature logger is included in the container, consistent with standard EU practice, to ensure full traceability of temperature conditions during shipping.

Shipping Info

Biogenis collects cord blood kits from the hospital immediately after birth with their own in-house couriers as well as by internationally reputable external courier partners (FedEx), operating 24/7 including weekends and public holidays. A dedicated 24/7 emergency line is available for birth announcements and courier dispatch. The Bucharest laboratory processes samples 6 days a week, including weekends and public holidays.

Pick-up service is included in the base price for all locations across Romania — there is no extra shipping charge within the country.

Processing Method

Biogenis stores exclusively stem cell concentrate — never whole cord blood — because whole blood has no established clinical use in transplantation, contains elements with potential toxicity, and transplant centers do not perform cellular separation. Over 90% of cord blood banks worldwide follow the same storage practice.

Cord blood processing steps (HSC): (1) Incoming analysis of maternal blood sample (HIV, HBsAg, HCV, CMV, syphilis, bacterial cultures, flow cytometry, ABO/Rh typing); (2) Automated cellular separation and HSC extraction using semi-automated equipment; (3) Gradual programmed cryogenic cooling; (4) Transfer to liquid nitrogen vapour cryogenic tanks at −196°C. Cell viability of stored samples averages >90% (industry standard: 75%).

Cord tissue processing steps (MSC): a 10–15 cm segment of umbilical cord is processed in the laboratory. Mesenchymal Stromal Cells are isolated from Wharton's Jelly, then cryopreserved at −196°C. Collection is possible in both vaginal deliveries and Caesarean sections, regardless of cord clamping timing.

Placenta Plus (available since October 2024): placental tissue is collected separately and cryopreserved.

Components Stored

Parents receive a detailed certificate upon completion of cryopreservation, describing cell counts, viability, and quality test results.

Components stored by Biogenis:

(a) HSC concentrate (cord blood stem cells) — stored in 2 to 12 individual cryogenic vials per sample, enabling multiple future therapeutic uses by multiple family members. The optional Opțiunea 120 add-on: if cord blood volume exceeds 120 ml, the sample is stored in 4 separate vials (2 cassettes × 2 compartments of 20% and 80%), allowing multiple independent treatments.
(b) MSC from umbilical cord tissue (Wharton's Jelly) — isolated and cryopreserved separately. The Mezenchimale Plus add-on provides double the quantity of MSC in twice as many individual vials.
(c) Maternal blood sample — retained for infectious disease testing (HIV, HBsAg, HCV, CMV, syphilis).
(d) Testing portions — reserved for quality control and future analysis.
(e) Placental tissue (Placenta Plus add-on, since October 2024) — cryopreserved separately.

Storage Method

Samples are stored in sealed cryogenic cassettes and cryopreserved at −196°C in the vapour phase of liquid nitrogen, in cryogenic tanks located in Biogenis's own accredited laboratory in Bucharest. The facility uses redundant cryogenic equipment with continuous 24/7 automated monitoring of temperature and nitrogen levels. Galaxy STEM packages include storage at FamiCord's laboratory in Poland or Switzerland.

Storage duration included in the base contract: 18 years. Storage is theoretically unlimited at −196°C — international studies confirm full cell viability after 24 years.

Licensing & Accreditation

(a) Hematopoietic Stem Cell Bank Accreditation — National Transplant Agency, Decision Nr. 15/05.08.2022, covering: cord blood, placental blood, and umbilical cord tissue & cells (valid 5 years)
(b) Placental Tissue Bank Accreditation — National Transplant Agency, Decision Nr. 28/17.07.2024 (valid 5 years)
(c) Sanitary Operating Authorization — Ministry of Health / Public Health Directorate of Bucharest Municipality, Nr. 921/10.07.2024, for Stem Cell Bank operations (CAEN code 8690)
(d) ISO 9001:2015 — Quality Management System certified by URS Certificări (certificate no. URS240187/0001/UAS/RO, issued 21 November 2024), covering stem cell laboratory collection and storage activities

Clinical Experience

Biogenis key figures as of 2026: 200+ Romanian patients treated with cord blood or stem cells; 58 samples released by Biogenis; 30,000 clients units stored, 18+ years of uninterrupted activity in Romania.
Famicord Group has released 278 cord blood units for therapy as of June 2026.
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.
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

As part of its commitment to clients, Biogenis offers the Neuro Transplant package, providing guaranteed access to autologous stem cell therapy for children diagnosed with autism spectrum disorder (ASD) or cerebral palsy (CP), up to 5 years of age. This program is available exclusively to clients whose cells are already stored with Biogenis, and is unique among Romanian cord blood banks. Biogenis is the most experienced Romanian bank for releasing stored samples for treatments in pediatric neurology, with over 200 Romanian patients treated to date.

Community Service

Loyalty Program 80-20 (permanent): an existing Biogenis client who refers a friend receives an 80% discount on their own annual storage fee. The referred friend receives a 20% discount on their chosen package. The referral discount is repeatable for every new referral.
Patient Navigator service: Biogenis is the only Romanian cord blood bank providing a dedicated Patient Navigator — a trained specialist who accompanies patients from diagnosis through to treatment, covering legislative, logistical, medical, and financial guidance, HLA typing coordination, and direct contact with transplant centers.
'Visit the Bank' program: families are invited to visit the Bucharest laboratory in person to see the storage facilities and meet the team.
Prenatal education partnerships: Biogenis participates in antenatal education programs across Romania and online, providing free information sessions for expectant parents.
Discounts for medical doctors.

Prices

Prices are paid only after birth, with no advance or deposit required. No fee is charged at contract signing or kit receipt. The first payment is triggered upon issuance of the storage certificate. Payment plans available: 3, 6, 9 or 12 equal interest-free installments. Online card payment available.

Main collection packages — storage in Romania (prices from official brochure, May 2026):

START: RON 3,500 enrollment/processing + RON 330/year storage — includes HSC (cord blood stem cell concentrate). 18 years storage included.

PREMIUM: RON 8,000 enrollment/processing + RON 400/year storage — includes HSC + umbilical cord tissue with Wharton's Jelly (MSC). 18 years storage included.

BABY VIP: RON 10,110 enrollment/processing + RON 400/year storage — includes HSC + MSC + complete mesenchymal cell isolation. 18 years storage included.

Galaxy STEM packages — international storage (prices on request):

Galaxy Poland: storage at FamiCord's central European laboratory in Poland — includes kit, transport, HSC processing, MSC isolation, cryopreservation in 2 vials, 18 years storage.

Galaxy Switzerland: all Galaxy Poland services + cord segment processing + 18-year storage in Switzerland.

Additional Services

Biogenis offers the widest range of additional services of any cord blood bank in Romania. Clients can configure their own custom package — unique in Romania.

Genetic services: DNA extraction, processing and purification from cord blood at birth (Romanian first); DNA banking for mother, father, and/or child; 101 Genetic Tests from urine (not blood) covering predisposition to 101+ genetic conditions (absolute Romanian first); DNA Advisor WES — Whole Exome Sequencing covering ~300 genetic diseases (metabolic and oncological).

Neuro Transplant package: guaranteed access to autologous stem cell therapy for children diagnosed with autism spectrum disorder (ASD) or cerebral palsy (CP), up to 5 years of age. Unique in Romania.

Opțiunea 120: if cord blood volume exceeds 120 ml, sample is processed into 4 individual vials (2 cassettes × 2 compartments of 20% / 80%) for multiple independent therapeutic uses.

Mezenchimale Plus: double quantity of Mesenchymal Stem Cells stored in double the number of individual vials.

Placenta Plus (since October 2024): collection and cryopreservation of placental tissue, maximizing the number of cells available and broadening potential therapeutic applications.

Patient Navigator / Transplant Assistance: a dedicated specialist guides the family through all legislative, logistical, medical, and financial steps from diagnosis to treatment, including HLA typing and coordination with transplant centers.