CAR-T Therapy Development Solutions

CAR-T Therapy

Chimeric Antigen Receptor T (CAR-T) cell therapy is an individual cell-based technique that genetically treated T cells (a type of white blood cell) removed from patients in the lab and produce special receptors called chimeric antigen receptors, or CARs. CARs allow the T cells to recognize an antigen at the surface of cancer cells and activate T cells' ability to kill these cancer cells. The CAR-T cells are then grown and multiplied in the lab. Once enough CAR T cells have been made, they will be given back to the patient to identify and destroy certain cancers. As planned, the CAR-T cells will continue to multiply in the patient's body and, with guidance from their engineered receptor, recognize and kill any cancer cells that harbor the target antigen on their surfaces.

With years of expertise in protein, antibody, and ELISA kit development, CUSABIO possesses an extensive range of research reagents for viral studies and provides high-quality technical services. We are dedicated to supporting various stages of CAR-T cell therapy development, including CAR development, CAR-T preparation, CAR-T cell quality control and preclinical evaluation.

CAR-T Therapy Development Solutions

CAR Development

CAR is the key element of CAR-T cell therapy and can be designed for specific tumor types. CARs consist of an extracellular ligand-binding domain, a spacer domain, a transmembrane domain, and one or more cytoplasmic domains. The extracellular ligand-binding domain of CARs typically is a single-chain variable fragment (scFv) and determines whether CAR-T can specifically recognize tumor cells and plays an important role in the efficacy and safety of CAR-T cells. scFv affinity and specificity have an important impact on CAR molecule function and can be modulated to reduce “on-target, off-tumor” side effects.

Target Proteins and Target Antigen Expression Service

Target antigens determine the specificity and effectiveness of CAR-T cells.With many years of experience in protein expression, CUSABIO has developed a series of target protein with different species and tags, which are suitable for immunization, screening, scFv affinity characterization and all kinds of testing needs. CUSABIO provides hematological tumor and solid tumor target proteins like CD19, CD20, CD22, CD38, BCMA, CD133, CD138, B7-H3, Mesothelin, GPC3, Her2, CLDN18.2, etc.

We offer a comprehensive range of five major recombinant protein expression systems to meet diverse requirements for expressing different virus antigens. Our services cover protein purification, quality detection, and control, ensuring the quality and purity of recombinant proteins.

Custom Antibody Service

With rich experience and expertise in antibody preparation, CUSABIO can provide services from antigen design and preparation, animal immunization to obtaining scFv sequence. CUSABIO can help to facilitate the development and screening of CAR candidates.

Stable Cell Lines and Customization Services

With years of experience in protein expression research, CUSABIO has accumulated extensive experience in the development of Stable Cell Lines. We can effectively enhance the production capacity of Stable Cell Lines and improve experimental results.CUSABIO offers a range of stable cell line products targeting common CAR-T targets, as well as stable tumor cell lines construction, fully supporting the functional verification of CAR-T cells and other needs.

ELISA Kit Products and Custom ELISA Kits Service

CUSABIO has 16+ years of experience in manufacturing ELISA kits and has formed a sound platform for the development of ELISA kits.

As a trustworthy ELISA kit supplier, we offer 4000+ ELISA test kits mainly in sandwich ELISA format, including 3000 targets, covering species of human, mouse, rat, bovine, etc.

CAR-T Preparation

In CAR-T cell therapy, white blood cells including T cells are removed and separated out from the patients’ blood. T cells need to be activated before CAR gene transduction and subsequent CAR-T cell expansion is required to support the production of CAR-T cell therapy drugs. CUSABIO can provide antibodies and a range of cytokines for T cells activation and expansion, and to improve the anti-tumor activity of CAR-T cells.

Antibodies

T-cell activation is critical to the success of the cell manufacturing process and CD3/CD28 antibodies are most commonly used for T cell activation in vitro. CD3 signaling triggers T-cell activation while CD28 signaling provides the necessary costimulation. CUSABIO provides high purity and high activity antibodies for CAR-T preparation.

Cytokines

Cytokines play an important role on the quality of T cells for CAR-T preparation. Cytokine cocktails,most commonly IL-2, IL-7, and/or IL-15—are used to influence the composition, quality and phenotype of the resulting CAR-T cell product. CUSABIO provide high quality cytokines for CAR-T cell therapy.

Quality Control

The quality of CAR-T cells are highly correlated with the clinical treatment effect. The product needs to be effective which is typically tested indirectly by assessment of transduction efficiency. The number of CAR positive cells can be determined by immunophenotyping of the CAR T cells at the end of production.

CAR-T Target Proteins

Efficient killing of tumor cells by CAR-T cells are required for their quantity and ratio. Although methods are available to test the positive cells, no standardized method is used. CAR protein drives antigen-dependent signaling, thus the CAR proteins can be used to stain and detect CAR-T cells directly to evaluate CAR functionality. CUSABIO successfully developed a range of recombinant CAR-T target proteins with diverse formats for CAR expression detection.

Custom Anti-idiotype Antibody Services

Anti-idiotypic antibody recognizes scFv fragments on CAR structures with higher specificity and sensitivity. CUSABIO provides services from antigen design and preparation, animal immunization to obtaining anti-idiotype antibody, facilitating CAR expression detection.

Flow Cytometry Antibodies

In CAR-T cells, quality control tests are performed to characterize the product and ensure its safety, purity and potency. Flow cytometry can be utilized to assess the purity of a CAR-T cell product, including the proportion of cells positive for T cell surface markers such as CD3, CD4, and CD8, as well as markers of the CAR, and the quality of FACS antibodies directly affects the accuracy of the test results. CUSABIO provides various antibodies for flow cytometry to perform quality control tests.

Preclinical Evaluation

CAR-T cells seeking clinical evaluation must meet defined product characteristics relating to safety and potency. CUSABIO provides high-quality cytokine ELISA kits and stable tumor cell lines to evaluate the killing activities and specificity of CAR-T cells in vitro.

Target Proteins and Target Antigen Expression Service

In CAR-T cell therapy, cytokines are produced to activate more immune cells to respond to cancer cells, however immune response can be potentially fatal in severe cases. Therefore, it is important to analyze the secreted proteins involved in specific pathways to characterize the cell-mediated cytotoxicity. CUSABIO has developed the IS series of Cytokine detection assay kits specifically for industrial clients, including pharmaceutical companies. Our products are suitable for a range of applications, including CRS detection, residual process material testing in drug manufacturing, pharmacokinetic experimental cell function evaluation, quality control in the development of cell therapy drugs, and pharmacological efficacy testing.

Custom Antibody Service

CUSABIO now offers services for the preparation of polyclonal rabbit anti-idiotype antibodies and monoclonal mouse anti-idiotype antibodies (anti-Fab, anti-ScFv). Leveraging our five major protein expression platforms and assay kit development platform, we can provide customers with a comprehensive service ranging from antigen preparation and Anti-idiotype Antibody development to the establishment of detection methods and the development of assay kits.

Stable Cell Lines and Customization Services

With years of experience in protein expression research, CUSABIO has accumulated extensive experience in the development of Stable Cell Lines. We can effectively enhance the production capacity of Stable Cell Lines and improve experimental results. CUSABIO offers a range of stable cell line products targeting common CAR-T targets, as well as stable tumor cell lines construction, fully supporting the functional verification of CAR-T cells and other needs.

Antibodies

CUSABIO offers a wide range of antibodies, including target antibodies and flow cytometry antibodies, for the detection and characterization of heterogeneous cell populations and to analyze target cell killing and effector cell phenotype.

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