Cell Material Supply
Since 1997, StemCyte has been dedicated to cord blood banking and clinical applications and has established an inventory of more than 36,000 publicly donated cord blood units. REGENECYTE®, StemCyte’s cord blood product, received U.S. FDA Biologics License Application (BLA) approval in 2024 (BLA No. 125764).
Building on nearly 30 years of experience in cord blood collection, donor screening, cell processing, quality testing, cryopreservation, and international supply, StemCyte has expanded its capabilities to provide cord blood, umbilical cord tissue, and their derived cellular materials. StemCyte provides cell therapy developers, CDMOs, and academic and research institutions with high-quality cellular materials supported by source management, quality testing, and documentation, with the goal of becoming a trusted strategic supply partner for advancing cell therapy product development and manufacturing worldwide.
Why Partner with StemCyte
Traceable Cell Sources
With its own public cord blood bank and extensive experience in long-term cell bank management, StemCyte can evaluate cell sources and supply specifications based on individual project requirements.Proven Quality Systems
StemCyte’s cord blood banks in the United States and Taiwan continuously maintain FACT and AABB international accreditations. StemCyte has also established experience in manufacturing, quality, and regulatory management through its U.S. FDA-approved BLA product.Project-Specific Solutions
Based on the stage of development, StemCyte can work with partners to define material formats, cell bank levels, testing requirements, batch documentation, and cryogenic shipping conditions.
Supply Portfolio
StemCyte provides cord-derived cellular materials at different stages of processing based on the intended research stage and application. Specifications, supply formats, and supporting documentation can be tailored to individual project requirements.
TIER 01 Starting Materials
Whole Cord Blood Units
Fresh/Frozen · Clinical Use / Research Use
Single-donor cord blood units are available with total nucleated cell (TNC) and CD34+ cell counts to support research and process evaluation.
Umbilical Cord Tissue
Fresh/Frozen · Clinical Use / Research Use
Wharton’s Jelly tissue obtained from umbilical cord segments can be provided as source material for the isolation and culture of mesenchymal stromal cells (MSCs).
TIER 02 Isolated and Cultured Cells
Umbilical Cord-Derived Mesenchymal Stromal Cells (UC-MSCs)
Frozen · Research Use
Mesenchymal stromal cells (MSCs) isolated and cultured from umbilical cord tissue. Research Cell Banks (RCB), Master Cell Banks (MCB), and Working Cell Banks (WCB) are established in accordance with GTP requirements. Batch-specific characterization reports can be provided, and customized specifications can be evaluated based on individual project requirements.
TIER 03 Co-development Programs
Cord Blood-Derived Immune Cells
Frozen · Co-Development
Based on project requirements, StemCyte can evaluate the isolation, activation, culture, and expansion of cord blood-derived mononuclear cells (CB-MNCs), natural killer cells (CB-NKs), and T cells (CB-Ts). Target purity, functional parameters, and release specifications will be defined based on mutually agreed project requirements.
MSC-Derived Extracellular Vesicles
Frozen · Co-Development
StemCyte can evaluate the preparation of extracellular vesicles (exosomes) derived from umbilical cord-derived MSCs based on project requirements. Particle size, particle concentration, characterization, and other quality specifications will be defined based on mutually agreed project requirements.
Other Customized Products
Frozen · Co-Development
Feasibility can be evaluated based on the intended use, manufacturing process, and quality requirements.
*Actual product availability, quantities, specifications, testing requirements, and batch documentation will be determined based on cell type, intended use, supply region, and project-specific requirements.
Quality Control and Testing
Prior to shipment, each batch of cellular material undergoes applicable testing based on the cell type, intended use, and agreed specifications. The quality control system encompasses cell processing, quality testing, and material release to ensure that all operations meet established quality standards.
| Test Item (As Required) | Testing Scope |
|---|---|
| Identity | Phenotypic characterization based on cell type and project specifications |
| Potency Assay | Evaluation of viable cell content and functional performance |
| Viability | Assessment of cell viability after processing and thawing |
| Donor Eligibility | Donor information provided according to the intended use and applicable regulatory requirements |
| Sterility Testing | Testing for sterility and microbial contamination |
| HLA Typing | HLA typing data for cord blood-related products available upon request |
Cryopreservation and Shipping
Cellular materials are processed using controlled-rate freezing procedures. Storage temperatures are continuously monitored with automated alerts for temperature excursions. Shipping conditions are planned according to material characteristics, destination, and project requirements. Validated cryogenic shipping containers are used, with temperature data loggers to monitor conditions throughout transportation and maintain the required temperature range, supporting both domestic and international delivery.
Applications
- Cell and Gene Therapy Development: Starting materials for nonclinical research and preclinical development and evaluation.
- HSC and MSC Research: Supports the isolation, culture, characterization, and process development of hematopoietic stem cells (HSCs) and mesenchymal stromal cells (MSCs).
- Extracellular Vesicle / Exosome Research: Supports the preparation, analysis, characterization, and product development research of MSC-derived extracellular vesicles and exosomes.
- Regenerative Medicine Research: Supports research in tissue engineering, disease modeling, and regenerative medicine.
Important Considerations Before Ordering
Please ensure that appropriate cryogenic receiving and storage equipment is available in accordance with the material specifications. Certain materials require storage at temperatures below -150°C. To maintain the quality and safety of biological materials, returns are generally not accepted once materials have been shipped.
Shipping methods, import/export permits, customs documentation, and allocation of responsibilities will be determined based on the destination and agreed terms of collaboration.
Based on the intended use and applicable local requirements, please ensure that all necessary reviews, approvals, and permits, including IRB, IBC, or other applicable authorizations, are in place.
Cellular materials are generally supplied for research or co-development purposes. If the materials are intended for human use, clinical trials, or pharmaceutical manufacturing, all necessary approvals must be obtained in accordance with applicable regulations. Such projects will be evaluated on a case-by-case basis and subject to written agreement between both parties.
Looking for Cellular Materials or Co-Development Opportunities?
Please provide your stage of research or development, intended use, required specifications, and destination. Our team will assist in evaluating the appropriate material format, supply conditions, testing requirements, and supporting documentation.