Storage facility and laboratory: Meets international GMP standards and Clean Room Class 10,000
Equipment and chemicals:
✓ Cell protecting reagents certified with GMP and U.S. FDA approval.
✓ Carefully inspected, selected, and quality-tested before use.
✓ Stem cell culture technology following international standards from the United States.
✓ Comprehensive system for testing bacteria, viruses, and overall cell quality.
✓ Temperature Control: Liquid nitrogen containers maintained at -196°C according to AABB U.S. standards, ensuring long-term cell viability and quality.
✓ Sterility Control: Maintains a completely sterile environment from collection in the delivery room to storage.
✓ Monitoring System: Nitrogen monitoring operates 24/24 with remote alarm signals and a three-source backup power system.
✓ AABB-Standard Equipment: All devices, boxes, and containers used for stem cell storage are certified to meet AABB U.S. standards for sample storage and transportation.
✓ IATA-Compliant Packaging: Packaging is certified to meet IATA (International Air Transport Association) standards and is environmentally friendly.
✓ Primary ID Barcode System: Prevents errors for future users.
AutoXpress 2 (AXP II) Platform: Biological storage system by Cesca Therapeutics in Rancho Cordova, California, USA
An FDA-certified, fully automated and closed system:
✓ Automates the processing of cord blood, achieving a Total Nucleated Cell (TNC) recovery rate of over 85%.
✓ Strong recovery of MNC and CD34+ cells after cord blood volume reduction, effectively reducing red blood cell content.
✓ Automated monitoring and quality control of each cord blood sample.
| RAW FORM | FRESH FOAM | |
| ADVANTAGES |
✓ Update on the latest regenerative technologies at the time when regeneration is needed ✓ Eligible for the extraction of new stem cell sources |
✓ Ready for immediate use |
| DISADVANTAGES | ❌ Meets customer usage needs more slowly than fresh storage | ❌ Unable to update with regenerative technologies at the time regeneration is needed
❌ Not qualified to meet the requirements for isolating new stem cell sources |
FSCB-Cryoviva offers customers both raw and fresh stem cell storage methods:
– Raw storage: Cryopreservation of umbilical cord segments ensures the highest cell quality. When customers need to use the cells, they can easily update to the latest regenerative technologies as medical science advances daily.
– Fresh storage: Meets customers’ immediate needs for regenerative stem cells after storage. (If the fresh storage method is chosen but there is no immediate need for use, this may reduce cell quality, as demonstrated above).
