Large-Scale Serum-Free Culture Service for UC-MSCs
The cell therapy and biopharmaceutical industry is facing critical bottlenecks in upstream production. On one hand, regulatory and market demands for cell product quality are increasingly stringent; on the other hand, intense R&D competition requires companies to establish and scale up production processes as quickly as possible. Traditional two-dimensional culture methods rely on manual operations, are difficult to scale, and suffer from batch-to-batch variability and contamination risks. These have become major obstacles hindering industrial translation.
Addressing this core challenge, Creative Diagnostics provides a professional Large-Scale Culture Technology Service for Umbilical Cord Mesenchymal Stem Cells. This service employs an advanced serum-free culture system and scaled expansion process, designed to help clients overcome key hurdles from process development to batch production. We achieve a stable expansion of UC-MSCs exceeding 100-fold within two weeks. The resulting cells exhibit not only high purity and viability but also meet the latest industry group standards across all quality control metrics, making them directly suitable for downstream therapeutic product development, mechanism research, and drug screening.
Core Service Content
Our services cover the entire chain from cell acquisition to final product delivery, offering flexible, customized solutions for our clients.
| Service Category | Specific Content and Description |
| Customized Process Development & Scale-Up | Personalized development and optimization of culture processes based on specific client needs (research goals or product objectives), providing stable scale-up support from laboratory scale to bioreactor level. |
| Full Serum-Free Culture System | Utilizes chemically defined, serum-free medium throughout the entire process, eliminating animal serum to fundamentally eradicate the risk of exogenous pathogen contamination and ensure consistency and traceability of cell products. |
| Stringent Quality Control & Testing | Provides a complete testing report accompanying the cell product, including cell viability, count, phenotypic identification (e.g., flow cytometry), functional validation, and comprehensive microbiological safety testing (bacteria, fungi, mycoplasma, endotoxins, and specific viruses). |
| Cell Cryopreservation & Banking Services | Offers professional programmed cryopreservation services, supporting the establishment of master/working cell banks. Cells are stored long-term in liquid nitrogen, ensuring high viability and functional characteristics post-thaw. |
Service Advantages
Our core technical advantage lies in the integration of efficient expansion, stringent quality control, and advanced processes. Relying on a stable serum-free culture system, we can achieve over a 100-fold expansion of UC-MSCs within two weeks, with cell quality strictly adhering to industry standards. Key phenotypic ratios (CD73+, CD90+, CD105+ >95%) and sterility (negative for viruses, bacteria, fungi, mycoplasma, endotoxins) are reliably verified. Furthermore, we can provide 3D culture solutions that further enhance cell function. The entire system is designed for clinical translation, emphasizing process stability, scalability, and compliance, aiming to provide clients with solid and reliable upstream process support from R&D to production.
Workflow
Clients present specific requirements (e.g., target cell quantity, application, special testing needs). Our technical team evaluates these and collaborates with the client to finalize the service plan, timeline, and deliverables list.
Clients provide qualified umbilical cord tissue samples or seed cells. Our laboratory receives the samples under standard conditions and immediately initiates cell isolation or recovery procedures, documenting the initial status.
The core expansion phase begins. Cells grow in strictly controlled (e.g., temperature, CO₂, pH) bioreactors or multi-layer culture systems. The entire process is monitored by experienced technicians, with regular sampling for online testing of key indicators (e.g., cell density, viability, metabolites) to ensure process control.
Upon reaching the target cell quantity, cells are harvested. Subsequently, a comprehensive quality testing of the cell product is performed, including sterility testing, phenotypic analysis (CD73+, CD90+, CD105+ >95%; CD34-, CD45-, HLA-DR-), and functional validation. Based on client requirements, cells are prepared as cryovials or fresh cells.
The complete cell product and detailed culture and testing reports are delivered. Our technical support team provides product usage guidance and can offer consultation on the application of cells in subsequent experiments as needed.
Stringent Product Quality Standards
We commit that every batch of UC-MSCs delivered undergoes rigorous quality control testing, with key metrics meeting or exceeding industry consensus standards.
- Cell Identity & Purity: Flow cytometry analysis shows that positive markers (CD73, CD90, CD105) have expression rates ≥95%; negative markers (CD34, CD45, HLA-DR) have expression rates ≤5%, ensuring high homogeneity of the cell population and characteristic mesenchymal stem cell properties.
- Cell Safety & Sterility: Following industry standards, cell products undergo microbiological testing including bacteria, fungi, mycoplasma, and endotoxins, with all results negative. Additionally, donor sources undergo strict screening for pathogens (e.g., HIV, HBV, HCV) to ensure safety from the origin.
- Cell Function & Viability: Post-thaw cell viability is ≥90%, with retained trilineage differentiation potential into osteogenic, adipogenic, and chondrogenic lineages. Some research-grade products can also provide validation data for immunomodulatory functions
- Genetic Stability: Karyotype analysis ensures cells maintain a normal genetic background during expansion, providing a foundation for long-term research and application.
In the wave of cell therapy, success depends not only on cutting-edge scientific concepts but also on the industrial capability to translate those concepts into safe, effective, and affordable products. Our technology platform acts like a precision bridge, connecting promising discoveries in the laboratory with the reality of scaled production. While you focus on target validation and mechanism exploration, we handle the challenges of upstream manufacturing.
