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Chimeric Antigen Receptor (CAR) technology is redefining cancer treatment by empowering the immune system to specifically target and eliminate tumor cells. By genetically modifying T cells or Natural Killer (NK) cells with synthetic receptors, CAR-T and CAR-NK therapies offer precise tumor recognition, resulting in remarkable clinical outcomes, particularly in hematological malignancies like B-cell acute lymphoblastic leukemia and certain lymphomas. These cell therapies are now considered the fourth therapeutic modality in oncology, joining surgery, radiotherapy, and chemotherapy.
Figure 1. Process of a typical CAR T cell therapy.
The standard manufacturing process includes the isolation of patient- or donor-derived immune cells, CAR gene integration via viral vectors, clonal expansion under strict conditions, and final delivery back into patients. However, high production costs, complex handling, long turnaround times, and safety concerns such as cytokine release syndrome (CRS) or neurotoxicity limit accessibility.
There is, therefore, a growing need in both academic and industrial sectors for reliable, cost-effective, and highly reproducible CAR-T/CAR-NK manufacturing platforms that meet stringent research and preclinical development standards.
Creative Biogene delivers comprehensive and customizable CAR-T and CAR-NK cell manufacturing services tailored to diverse research needs. Leveraging extensive lentiviral packaging capabilities, a robust CAR library, and scalable workflows, we provide high-yield, high-fidelity cell products optimized for functional assays, animal models, or translational pipeline validation.
Core offerings include:
| Assay | Methodology |
| Morphology | Phase-contrast microscopy |
| Viability & Cell Count | Trypan blue exclusion, automated cell counter |
| Phenotypic Markers | Flow cytometry (CD3/CD56, CAR+, memory markers) |
| Sterility | Direct inoculation and membrane filtration |
| Endotoxin | LAL gel-clot and kinetic turbidimetric assays |
| Mycoplasma | qPCR and DNA staining |
| CAR Expression | qPCR and surface flow staining |
| Cytotoxicity | LDH, Calcein-AM, RTCA, and luciferase assays |
| Cytokine Release | ELISA, Luminex kits |
| Vector Copy Number | ddPCR |
| Genetic Knockouts | Flow cytometry and Sanger sequencing |
Cell Types Supported:
Customization Options:
Specialty Services
Our team includes scientists with decades of experience in immunotherapy, viral vector systems, molecular cloning, and flow cytometry. We maintain biosafety level P2+ laboratories and advanced instrumentation to ensure scalability and reproducibility:
In an era where precision and speed define the pace of immunotherapy research, Creative Biogene stands out as a trusted and agile partner for CAR-T and CAR-NK cell development. Whether you're validating a novel target, optimizing CAR constructs, or preparing for in vivo studies, our comprehensive suite of services—from murine to humanized platforms—ensures reliable results with scientific rigor. With flexible customization, rapid turnaround, and unwavering quality standards, we empower scientists and biotech innovators to move from concept to functional cell products seamlessly. Partner with us to accelerate your CAR research—customized, uncompromised, and always one step ahead.
CAR-NK Cell Development Services
CAR-T Cell Development Services
cGMP Cell Line Production Process
CAR-T Lentiviral Particles
CAR Lentiviral Packaging Service
CAR Plasmid Preparation Service
Q1: Can Creative Biogene help me design a novel CAR construct if I only have a target antigen in mind?
Absolutely. Our team of molecular immunologists and structural biologists will work with you to select or humanize the appropriate scFv or nanobody, design a CAR construct with optimal hinge, transmembrane, and intracellular signaling domains, and ensure compatibility with your target cell type. We also validate the binding efficacy in silico and in vitro.
Q2: What are the quality and reproducibility guarantees for the CAR-T/NK products?
Each cell product undergoes a stringent QC process, including identity confirmation, viability assessment, CAR expression levels, endotoxin and mycoplasma testing, and functionality via cytotoxicity assays. We use standardized protocols and maintain detailed batch records to ensure consistency across replicates and orders.
Q3: How do you ensure biosafety in your CAR-modified cells, especially regarding insertional mutagenesis?
We use third-generation self-inactivating (SIN) lentiviral vectors with enhanced safety profiles, and we test for replication-competent viruses. All vector backbones are rigorously validated for insertional safety. For clinical transitions, we can assist with integration site analysis and additional biosafety evaluations.
Q4: Can Creative Biogene support large-scale production or GMP transition?
Yes. While our core facility supports preclinical-grade production, we work closely with GMP-compliant partners and CDMOs to offer scale-up solutions and regulatory-grade production pipelines. We can provide tech transfer packages and documentation for seamless GMP transition.
Q5: Do you provide support for regulatory documentation or IND filing assistance?
While we do not directly submit regulatory documents, we support clients by providing detailed protocols, batch records, QC results, CMC documentation outlines, and consultative assistance for IND-enabling studies.
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