Family Bank: FamiCord - Suisse

About

FamiCord Suisse SA is owned by FamiCord Group, one of the largest cord blood banks in the world and No.1 in Europe. FamiCord is the only cord blood bank in Europe which has  EU authorization to release therapies based on cord tissue and placenta.

Labs and Locations

• Famicord Suisse has customer office located BusinessPark Zug, Sumpfstrasse 26, 6302 Zug, Switzerland
• Famicord Suisse has laboratory located Via Chiossascio 6, 6594 Contone, Switzerland
• As of fall 2023, Famicord Suisse is only providing storage services, and processing of new samples is performed at Famicord/PBKM in Poland

Business Experience

FamiCord Suisse SA is part of the FamiCord Group, Europe's leading stem cell bank, which stores stem cells from different sources: umbilical cord blood, umbilical cord tissue, and placental tissue. Thanks to our ongoing commitment to cellular biotechnology, we have developed, over the years, highly specialized know-how and state-of-the-art methods in processes, storage, quality control and release of stem cells.

FamiCord Suisse is the result of the Famicord acquisition of Biocell Lugano SA, a company born in 2007 with considerable experience in the field of medical research and in particular in molecular genetics. In July 2020, FamiCord Suisse merged with Stemlab AG, a company in Portugal with high expertise on marketing and sales services in connection with stem cells and tissues.

In order to promote quality and safety in processing and preservation techniques, FamiCord Suisse employees are trained to the highest industry standards. In addition to Swissmedic accreditation, the laboratory maintains both GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) certificates. The Scientific Management is also highly qualified: Our Medical Director is a highly experienced hematologist with more than 25 years of experience in oncology field and stem cell transplant. His experience is evidenced by hundreds of scientific publications and presentations at top international congresses. Our Scientific Director, obtained also a master in manufacturing of ATMP (Advanced Therapies Medicinal Products), fundamental to develop protocols for regenerative medicine.

Collection Kit

The FamiCord Suisse collection kit is made by an external company specialized on logistics and transport of biological materials and drugs. It was developed on the basis of infectious substances shipping guidelines from International Air Transport Association (IATA) as well as accordance with any applicable European standards.

The kit component parts are:

1) The cord blood collection bag, is made and certified by RAVIMED. 
The RAVIMED R Set-A200C bag contains 21 ml solution of anticoagulant CPD (CPD) in the main container, for taking 200 ml of cord blood, and 8 ml of CPD anticoagulant solution (CPD) in an additional little bag, important to wash the tube after the collection, not to lose a single drop of the blood collected. The polymer container has unique identification numbers; sterile disposable needle, needle stick protection (PSG). The container is equipped with two sterile needles (one as backup of the other) coated with silicone for painless venipuncture with a protective cap and an indicator mark to easily determine the cut of the needle and prevent injury to the donor’s vein. The top and bottom of the blood container has rounded corners to improve fluid flow dynamics. The collection bag has a double-packaging, to meet the sterile requirements of the operating theatre in case of C-section.

2) Sterile Disinfection equipment.
Disinfectant of brand Cha-ha, disinfection swabs, sterile gloves, surgical mask and sealed sterile wrap are provided to ensure sterility during blood draw.

3) Datalogger (Tempmate®-M1).
This device is able, upon activation, to record temperature data from the moment of the kit delivery to the parents, to the sample collection and insertion into the kit, until the delivery to the lab. The maintenance of the temperature of the sample inside an acceptable-for-processing (10-26 °C) is crucial to ensure a good-quality sample; the datalogger allows to keep tracking of temperature variation above and below these values. The operator receiving the kit checks the temperature data and if not-in-range, can be performed a quality test to ensure the viability of stem cells.

4) Vivomed jelly packs (REF 69710073) .
These are thermostatic packs that have the purpose of maintaining the temperature inside the box during the transport. The jelly pack is essential to maintain the sample in the range of temperature ideal to warranty the quality of the sample (10-26 °C). FamiCord Suisse collection kit it is completely validated to maintain this range also in the worst-case scenarios.

5) Plastic bag Halinex and Amersafe are secondary bags that have the purpose of enveloping the primary container (collection bag). From FACT-Netcord regulation v7 (C7.3), the primary cord blood collection bag shall be placed in a sealed secondary plastic bag to contain any leakage from the primary bag.

6) Sharp blunt scissors, disposable tweezers, needle and 7.5 mL syringe are provided in the kit in order to help the obstetrician at the moment of collection favoring an optimal sample collection and quality.

7) Two 7.5 mL EDTA vials for maternal plasma collection (REF 01.1605.001, SARSTEDT). During delivery, two aliquots of maternal blood are collected in order to test for infectious diseases.

8) For the tissues (cord tissue and placenta), the kit contains dedicated containers, salt solution to keep the tissues moist, and secondary bags to envelop the primary containers.

9) The collection kit contains, in addition to the documents for the parents-to-be, the collection procedures for the staff of the birth center, labels to ensure traceability of the products, and the collection report that is filled in by the person in charge of the collection. FamiCord Suisse also organizes training courses for the collection centers, in order to collect biological samples in the best possible way to assure a future therapeutic use of these products.

Transportation container

The biological samples are transported inside FamiCord Suisse transport kit that follows the prescription of International Air Transport Association (IATA PI 650) which regulates Biological Substances (Category B, UN 3373). This regulation is the international standard for transport of diagnostic samples. The transport kit has been validated to ensure the transport of the biological samples in optimal conditions. Inside a cardboard box is present an insulating box of polystyrene that together with jelly packs ensures the insulation and the maintenance of sample temperature for the duration of many days.

Shipping Info

After the collection of the cord blood in the delivery room, performed usually by an obstetrician, the parents call FamiCord Suisse to organize the transport. FamiCord Suisse has a dedicated courier for the transport of the samples. Thanks to their digital platform, FamiCord Suisse staff can track each kit at any time. Both the courier and the FamiCord Suisse lab work 7 days a week, assuring the samples are picked up and processed even during the weekends and the public holidays. This is included in the base service fee.

The FamiCord Suisse courier partner has a long experience on transport of biological materials since 1999, in particular of medical samples that are not replicable. They own ISO 9001 certification since over 10 years and thanks to their more environmentally-friendly method of transport, they have been awarded of the Swiss climate sustainable business certificate. The courier will pick up from the hospital as soon as possible, but latest in 40 hours; then the samples are delivered to the FamiCord Suisse laboratory. Regulations require that the cord blood must be delivered to the lab and processed and frozen within 72 hours from the collection date. 

Processing Method

Once FamiCord Suisse laboratory receives the kit, the operator carries out the acceptance phase of the samples and starts with the processing. FamiCord Suisse personnel are trained to perform a manual separation of the cord blood by sedimentation & centrifugation. This processing method allows a higher stem cell recovery than that obtained with automated systems. Another advantage of the FamiCord Suisse protocol is that it uses a completely closed system, thus ensuring complete sterility of the sample during all stages of the process.

• The collection bag is cleaned, weighed, and some reference samples are taken and stored in case further analysis are needed in the future (such as genetic tests, HLA typing).
• Then a proportional volume of HES (hydroxyethyl starch) is added to enhance the sedimentation of the red blood cells and concentrate the stem cell progenitors, reducing the cord blood volume.
• Umbilical cord blood is moved from the collection bag to a transfer bag thanks to a heat-sealing system. The blood bag is placed on a plasma expressor in order to obtain the red blood cell sedimentation and the formation of the buffy coat, which is the white blood cell portion of the blood that is rich in stem cells.
• The plasma and the buffy coat are then collected and centrifuged.
• The separated buffy coat unit is thoroughly mixed to re-suspend the cells in the residual plasma. After a slow addition of the Cryoprotectant agent, 10% DMSO, the cryobag containing stem cells is placed in a metal canister and then enters a computerized temperature-reducing system.
• After temperature reaches -120°C, the sample is moved to a permanent storage tank where vapors of cryogenic nitrogen maintan the temperature at -196°C.

FamiCord Suisse also processes tissue from the umbilical cord and placenta. Unlike cord blood, the tissues process, according to the current state of the art, takes place in an open system and not a completely closed one. For this reason, these samples are processed inside isolators. FamiCord Suisse decided to invest in this isolator technology for GMP cell processing to ensure the highest quality of processed samples. The isolators minimize human interaction during processing, which results in a significant decrease in risk of microbiology contamination from the environment.

Components Stored

Umbilical Cord blood (UCB) main components are subdivided during processing: plasma, red blood cells, and white blood cells. White blood cells are isolated for storage because this portion is rich in hematopoietic stem cells. Based on current international accreditation standards, FamiCord Suisse stores for each sample:

• UCB reference sample collected from the original collection bag
• Aliquot of UCB plasma
• UCB reference samples, after the process, segments attached to the freezing bag
• Aliquots of maternal blood
• Aliquots of maternal plasma

Several quality tests are performed during processing: complete blood cell count (CBC), nRBC, TNC, WBC recovery, CD34+ cell viability and concentration, microbiological analysis, ABO group. Maternal blood tests for infectious diseases are reported as well. Upon careful revision by the quality and production Managers as well as of the Medical Director, the release certificate is issued. 

Storage Method

FamiCord Suisse identifies each cord blood unit by a unique label following international standard ISBT128 regulation. The cryobag is protected by an external metal canister and it is cooled down to -120°C by a computer-programmed freezer that ensure a slow change of temperature over time. At the end of the freezing protocol the sample is positioned in a metal rack inside a cryogenic nitrogen tank at -196°C. The temperature of the samples inside the tanks are constantly recorded and controlled by a remote monitoring system and by operative personnel, guaranteeing the samples stability over time. 

Licensing & Accreditation

FamiCord Suisse is licensed and regularly inspected by Swissmedic, the Swiss Agency for Therapeutic Products. FamiCord Suisse is authorized by Swissmedic to manufacture cell therapy products (from tissues like cord tissue and placenta), to trade in such products (in Switzerland and abroad), and to transport such products (both import and export). On the basis of this authorization, FamiCord Suisse holds both GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) certificates, fundamental for the processing and storage of the samples but also for the transport in case of release for transplant.

Based on the Federal Act of 8 October 2004 on the Transplantation of Organs, Tissues and Cells (Transplantation Act) and on the relative ordinance, a tissue bank that wants to use the stem cells samples in a family setting, has to be authorized by the FOPH (Federal Office of Public Health). FamiCord Suisse is authorized by FOPH for process, storage, import and export of cord blood stem cells for autologous and family use (related use).

In addition to these Swiss government licenses, FamiCord Suisse has established a rigorous Quality Control department. The Quality Control lab carries out the complete characterization of the processed and released samples using different technologies (microscopy, PCR, cytofluorimetry, microbiology, proficiency test, etc.) and issues the corresponding certificates of analysis.Thanks to a quality system based on compliance with the most recent national and international guidelines, we ensure full traceability of the samples processed in our laboratories and of the biobank's control functions. Our quality department is regularly subjected to external quality controls (e.g. CSCQ, Swiss Quality Control Centre).

Clinical Experience

FamiCord Suisse is a member of the FamiCord Group, the leading stem cell bank in Europe (over 550.000 stored samples), having extensive experience in the collection, processing, storage and release of human stem cells for therapeutic applications. FamiCord is active in stem cell research for various diseases, it is networked with leading transplant centers worldwide, and currently participating in 8 clinical trials. FamiCord Group has released more than 700 therapies in clinical trials and treated over 1500 patients.

FamiCord Group is the only private tissue bank in Europe which has authorization to release therapies based on tissues. Famicord Group owns two laboratories authorized to manufacturer ATMPs (Advanced Therapies Medicinal Products) based on tissues or cells.

FamiCord Group launched a treatment program (Expanded Access Europe) of using cord blood and cord tissue stem cells in treating cerebral palsy and autism. It means that FamiCord clients from all of Europe can have access to innovative stem cell therapies. The hospital partner of this project is University Children’s Hospital in Lublin, Poland.

Community Service

FamiCord Suisse offers a Transplant Assistance Package to families that may need to use their cord blood cells in a Hematopoietic Stem Cell Transplant (HSCT) for a standard medical indication. Experimental medical treatments are not covered. This package includes:

• Hematologist or transplant doctor consultation
• Transplantation HLA test
• CD 34+ cells and nucleated erythrocytes count (from a defrosted reference sample)
• Cells viability test and WBC count (from a defrosted reference sample)
• Hematopoietic progenitor cells count (from a defrosted reference sample)
• Delivery of cells from the place of storage to any transplantation center in the world

Prices

Storage for 25 years
Blood Standard: 250 CHF initial fee + 3200 CHF service fee = 3450 CHF total
Blood & Tissue Standard: 250 CHF initial fee + 3600 CHF service fee = 3850 CHF total
Blood &Tissue Premium: 250 CHF initial fee + 4000 CHF service fee = 4250 CHF total
Blood, Tissue and Placenta Platinum: 250 CHF initial fee + 4700 CHF service fee = 4950 CHF total

Additional Services

FamiCord Suisse offers the chance to store also tissues:

Cord Tissue. With this service, fragments derived from the Warton’s Jelly are cryopreserved as intermediate product following a specific protocol in the FamiCord Suisse GMP laboratory. If required, these fragments can be used to prepare the a cellular product ready for treatment. The preparation would be performed in one of the FamiCord laboratories authorized to produce ATMPs from tissue and cells, as required by international regulation.

Placenta. With this service, fragments are obtained from the placenta and cryopreserved following a dedicated protocol in the FamiCord Suisse GMP laboratory. If required, these fragments can be used to prepare the a cellular product ready for treatment. The preparation would be performed in one of the FamiCord laboratories authorized to produce ATMPs from tissue and cells, as required by international regulation.