Large-Scale Serum-Free Culture Service for TIL
In the field of tumor immunotherapy, while CAR-T therapies have achieved remarkable success in hematological malignancies, they still face significant challenges in treating solid tumors. As a revolutionary personalized immunotherapy, Tumor-Infiltrating Lymphocyte (TIL) therapy has become one of the most promising cell therapies to overcome solid tumors. TILs are immune cells isolated from a patient's own tumor tissue that have already recognized and infiltrated the tumor. Primarily composed of CD3+ T cells, they possess the innate ability to recognize and attack the patient's specific tumor cells. Compared to gene-modified therapies like CAR-T, TILs can target multiple tumor neoantigens and, being autologous, carry a lower risk of rejection.
However, the core bottleneck in transforming TIL therapy into a routine treatment lies in the manufacturing process: How to stably and efficiently expand a sufficient quantity of highly active TIL cells from limited starting tumor tissue, all while meeting clinical standards. Our TIL large-scale culture service is designed to address this central industrialization challenge. Leveraging our mature thousand-fold immune cell expansion platform and a full-process serum-free culture system, we are committed to providing comprehensive support for research institutions and pharmaceutical companies throughout the entire cycle—from process development and preclinical research to the production of clinical trial materials.
Core Service Content
We provide customized services covering the entire TIL cell preparation chain, ensuring every step from tissue to product meets high-quality standards.
| Service Module | Specific Content & Description |
| Tumor Tissue Processing & Primary TIL Isolation | Receives client-provided tumor tissue samples (fresh or properly preserved) and, in a qualified laboratory environment, efficiently isolates infiltrating lymphocytes from the tumor using optimized protocols like enzymatic digestion. |
| TIL Cell Activation & Large-Scale Rapid Expansion | Utilizes a chemically defined, serum-free medium system supplemented with an optimized cytokine cocktail (e.g., IL-2). Activation and large-scale expansion are conducted within closed culture systems, employing a rapid expansion protocol during the core phase to achieve high cell yields in a short timeframe. |
| Full-Process Phenotypic & Functional Monitoring | Conducts dynamic monitoring throughout the culture process. We track not only total cell count and viability but, more critically, analyze the proportion changes of key functional T cell subsets like CD3+CD8+. Functional validation data against autologous tumor cells can also be provided. |
| Comprehensive Cell Product Release Testing | Performs stringent release testing on the final product per industry consensus and guidelines. Beyond cell count and viability, core metrics include: CD3+CD8+ cell proportion >80%, sterility testing (bacteria/fungi), mycoplasma testing, endotoxin testing, and specific virus screening. |
| Cell Formulation, Cryopreservation & Shipping | Provides final formulation suitable for cell therapy products, controlled-rate cryopreservation services, and ensures product shipment under strict cold-chain conditions to maintain cell viability and function. |
Service Advantages
Our core technical advantage lies in the efficient integration of thousand-fold expansion capability, precise functional cell enrichment, and a complete quality assurance system designed for clinical translation. Leveraging our mature platform for scalable immune cell culture, we achieve a stable 1000-fold expansion of TILs within approximately two weeks, while ensuring the proportion of core cytotoxic CD3+CD8+ T cells in the final product consistently exceeds 80%. The entire production process employs a chemically defined, serum-free culture system, with all batches undergoing rigorous testing to confirm they are negative for viruses, bacteria, fungi, mycoplasma, and endotoxins. This validated, standardized process not only demonstrates the platform's exceptional robustness and scalability but is also comprehensively aligned with the requirements for clinical translation of cell therapy products. It is designed to provide clients with a reliable and compliant upstream manufacturing solution for the rapid progression from R&D to clinical trials.
Workflow
Both parties confirm tumor sample type, target cell quantity, specifications, and customized QC requirements based on research objectives or clinical filing needs, resulting in a detailed technical service proposal.
The client ships the tumor tissue sample. Our laboratory receives, logs, and assesses the sample condition under standard conditions and immediately initiates the TIL isolation procedure.
TIL cells undergo activation and expansion under strictly controlled parameters. We provide regular process monitoring reports, including cell growth status and key phenotypic data, ensuring transparency and control.
Upon reaching the target cell quantity, cells are harvested, formulated, and cryopreserved. A full suite of release tests is performed on the final product, generating a Cell Product Certificate of Analysis.
We deliver all raw data, analysis reports, the cell product, and a complete project dossier, providing solid data support for the client's subsequent research or regulatory filings.
Stringent Product Quality Control
We have established a multi-layered quality control system to rigorously monitor the key attributes of TIL cell products.
- Defined Cell Identity & Purity: Precise quantification via flow cytometry ensures that CD3+CD8+ cytotoxic T cells constitute >80% of the final product. This proportion is a core indicator of the cell population's anti-tumor potential.
- Excellent Cell Viability: Cell viability at harvest is typically ≥90%, and cells maintain high vitality post-thaw, ensuring effectiveness in subsequent functional assays or clinical applications.
- Comprehensive Sterility & Biosafety: Following pharmacopoeia and relevant guidelines, products must pass a full panel of sterility tests including bacteria, fungi, mycoplasma, and endotoxin, with corresponding negative test reports provided.
- Optional Cell Function Verification: Upon client request, we can provide In vitro killing assay data of TIL cells against autologous tumor cells or specific tumor cell lines, serving as key evidence of the product's functional activity.
