Large-Scale Serum-Free Culture Service for NK Cell
Natural Killer (NK) cells are core members of the innate immune system, capable of directly recognizing and killing tumor cells and virus-infected cells without causing graft-versus-host disease, demonstrating immense potential in the development of universal 'off-the-shelf' cell therapy products. However, transforming them from a laboratory research tool into a clinically applicable drug faces two core challenges: First, quantity—NK cells are scarce in patient peripheral blood, and traditional expansion methods are inefficient and batch-unstable, making it difficult to meet therapeutic dose requirements. Second, quality—obtaining cell products with high purity, high killing activity, and free from pathogen contamination is essential.
To address this, Creative Diagnostics offers a professional large-scale culture service for NK cells. Leveraging our established thousand-fold immune cell expansion platform, we can achieve stable and efficient expansion of NK cells exceeding 1000-fold within two weeks. We provide cell products that meet stringent quality standards, directly supporting your full spectrum of needs from preclinical research and process development to IND submission.
Core Service Content
Creative Diagnostics provides comprehensive, flexible, and customizable NK cell production solutions from seed cells to final product.
| Service Module | Specific Content & Description |
| Multi-Source Seed Cell Expansion | Supports initiation from various sources provided by clients, such as peripheral blood mononuclear cells (PBMCs), cord blood, or specific cell lines. High-activity NK cells are produced at scale through optimized activation and expansion protocols. |
| Large-Scale Serum-Free/Feeder-Free Culture | Utilizes chemically defined, serum-free medium throughout the entire process without the need for irradiated feeder cells. Expansion is conducted in closed bioreactors or culture systems, ensuring process stability, scalability, and compliance. |
| Rigorous Phenotypic & Functional Monitoring | We monitor not only cell count and viability but also dynamically assess cell phenotype (e.g., CD56+, CD3-, activation/inhibitory receptor profiles) and killing function (e.g., cytotoxicity against target cells like K562) during the expansion process. |
| Comprehensive Release Testing & Viral Clearance Validation Support | Performs a full suite of safety tests on each final product batch (sterility, mycoplasma, endotoxin, specific viruses). We can also provide a data package assessing the process steps' capacity to clear/inactivate potential viruses, supporting IND submissions. |
| Cell Cryopreservation & Formulation Development Support | Provides cell cryopreservation services compliant with cold-chain transport requirements. We can also assist clients with cell formulation research and stability testing to optimize the storage and use conditions of the final product. |
Service Advantages
Our core technical advantage lies in the deep integration of thousand-fold expansion efficiency, defined functional phenotype, and industrial production compliance. Leveraging our mature platform for scalable immune cell culture, we achieve stable expansion of NK cells up to 1000-fold within two weeks. The final product consistently maintains a functional CD3-CD56+ NK cell proportion above 70%, with all batches confirmed sterile (negative for viruses, bacteria, fungi, mycoplasma, and endotoxins). This validated platform not only demonstrates the exceptional robustness of our process but also provides a solid foundation for your seamless scale-up from research to clinical-grade production.
Workflow
Based on research goals or regulatory requirements, both parties confirm the seed cell source, target cell quantity, specifications, and special quality control metrics, followed by signing a technical service agreement.
We receive and process client-provided samples or use designated cell lines to initiate the directed activation and early expansion protocol for NK cells.
Cells undergo large-scale culture under strictly controlled parameters. We provide regular process monitoring reports containing cell counts, viability, phenotype, and key metabolic indicators.
Upon reaching the target, cells are harvested and formulated. The product undergoes full release testing, generating a Cell Product Certificate of Analysis.
We deliver all raw data, analysis reports, the cell product, and a complete Process and Quality Dossier to meet requirements for technology transfer or regulatory filing.
Stringent Product Quality Standards
We implement a strict multi-dimensional quality evaluation system for every batch of NK cell products.
- Cell Purity & Key Phenotype: Confirmed by flow cytometry, the final product has a CD3-CD56+ NK cell proportion >70%. Analysis data for activation receptor expression profiles (e.g., CD16, NKG2D, NKp46) can be provided upon request.
- Cell Safety & Sterility: All product batches are tested by authorized testing agencies or internal QC compliant with GLP standards, ensuring negative results for bacteria, fungi, mycoplasma, and endotoxin testing, along with screening for relevant viral items.
- Core Functional Activity: Standard cytotoxicity assays (e.g., LDH release or flow cytometry) are used to detect the cells' killing efficiency against sensitive target cells like K562. Functional validation data is provided to ensure the cells possess potent in vitro killing capability.
- Cell Viability & Proliferative Potential: Cell viability at harvest is ≥90%, and post-thaw recovery viability is typically ≥80% (subject to specific formulation).
