Large-Scale CD34+ HSCs Expansion Service
Hematopoietic stem cell transplantation is a crucial treatment for hematologic malignancies, immunodeficiency diseases, and inherited blood disorders. However, traditional transplantation is limited by the insufficient quantity of HSCs in a single cord blood unit, which can lead to delayed engraftment or graft failure in adult patients. The rapid development of the cell therapy industry has created an urgent demand for high-quality, scalable sources of CD34+ hematopoietic stem cells. On one hand, clinical and regulatory requirements for cell product purity, viability, and safety are increasingly stringent. On the other hand, the time and cost pressures of research and production necessitate the rapid establishment of stable and efficient large-scale manufacturing processes.
To address this core challenge, leveraging our established stem cell scale-up platform, we offer a professional large-scale expansion service for CD34+ hematopoietic stem cells. This service aims to efficiently transform limited starting cord blood samples into ample, fully functional HSCs, providing a reliable cell source for downstream clinical research, drug development, and exploration of novel therapies.
Core Service Content
We provide a one-stop, customizable solution from cell source to final product.
| Service Module | Specific Content |
| Cord Blood Mononuclear Cell Preparation & CD34+ Enrichment | Professional isolation of mononuclear cells from client-provided cord blood samples, followed by further enrichment of a high-purity CD34+ starting cell population using established methods. |
| Large-Scale Serum-Free Expansion Culture | Utilizes chemically defined, xeno-free serum-free medium for scale-up expansion in fully closed or controlled culture systems (e.g., bioreactors), minimizing contamination risk and batch-to-batch variation. |
| Rigorous Full-Process Quality Monitoring | Provides monitoring of critical quality attributes throughout the entire process, including cell counting, viability, expansion fold tracking, as well as final product phenotypic purity (CD34+) and functional validation. |
| Comprehensive Cell Product Release Testing | Mandatory sterility testing (bacteria, fungi, mycoplasma) and endotoxin testing are performed on the final cell product. Additional in-depth virus screening and genetic stability assessment can be conducted per client request. |
| Cell Cryopreservation & Formulation | Expanded cells are cryopreserved via controlled-rate freezing according to standard operating procedures. Cells are provided in transport-ready cryovials along with a supporting Cell Product Certificate of Analysis. |
Service Advantages
Our core technical advantage lies in the integration of efficient expansion, high-purity output, and a comprehensive safety system. Leveraging a mature serum-free culture process, we can achieve a stable expansion of cord blood-derived CD34+ hematopoietic stem cells up to 100-fold within two weeks, while ensuring the CD34+ cell purity in the final product consistently exceeds 95%. All batches pass stringent sterility testing (negative for viruses, bacteria, fungi, mycoplasma, and endotoxins). This verifiable standardized platform not only demonstrates the robustness of our process for stem cell expansion but also, through accumulated experience, lays a solid foundation for the broad applicability of our platform (e.g., supporting thousand-fold immune cell expansion) and its future flexibility in meeting diverse cell production needs.
Workflow
We discuss specific client requirements (target cell number, intended use, special testing requests, etc.) and provide a personalized project proposal and quotation.
The client provides qualified cord blood samples. Upon receipt, our laboratory assesses sample quality and initiates the cell isolation and enrichment procedure.
CD34+ cells undergo expansion culture under strictly controlled conditions. Regular sampling is performed to monitor key parameters such as growth status, density, and viability.
Upon reaching the target expansion goal, cells are harvested. Final phenotypic analysis, sterility/safety testing, and functional validation are performed on the cell product.
We deliver the complete Cell Preparation and Testing Report along with the cryopreserved cell product. Technical guidance for cell thawing and use is also provided.
Stringent Product Quality Standards
We commit that every batch of CD34+ hematopoietic stem cell product delivered adheres to a strict quality control system, with core standards as follows:
- Cell Identity & High Purity: Rigorous flow cytometry analysis ensures the CD34+ cell purity in the final product consistently exceeds 95%. This is the core identity marker guaranteeing the hematopoietic stem/progenitor cell characteristics of the population, laying the foundation for its subsequent engraftment and multi-lineage differentiation potential.
- Excellent Cell Viability & Proliferative Capacity: Pre-cryopreservation cell viability is ≥90%, and process monitoring confirms its robust in vitro expansion capability, ensuring cell performance in downstream applications or secondary expansion.
- Comprehensive Microbiological Safety: Following industry standards, the final product must pass a full suite of sterility tests including bacteria, fungi, mycoplasma, and endotoxins, all with negative results, ensuring freedom from exogenous microbial contamination.
- Reliable Functional Activity Validation: We perform functional validation on cell products via Colony-Forming Unit (CFU) assays, confirming their ability to effectively form multi-lineage hematopoietic colonies. This is a key gold-standard method for assessing HSC functional activity.
- Safe Cell Source & Genetic Stability: The starting cord blood source undergoes strict screening for specific pathogens. We can also perform karyotype analysis to ensure cells maintain a normal genetic background during expansion, providing safety assurance for long-term research and translation.
