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Application: Positive control for anti-CD19 CAR-T cellsScreening inhibitors or activators of anti-CD19 CAR-T cytotoxicityDesign and optimize co-culture cytotoxicity assay
Background: CD19 (also known as Cluster of Differentiation 19, B-lymphocyte surface antigen B4, or CVID3) is a glycoprotein expressed at the surface of B lymphocytes through most phases of B cell maturation. It is strictly required for B cell terminal differentiation. Mutations in the CD19 gene cause severe immune-deficiency syndromes associated with impaired antibody production such as CVID3 (common variable immuno-deficiency 3). The majority of B cell malignancies express normal to high levels of CD19, which is a nearly ideal target for cancer immunotherapy. Blinatumomab, a CD19/CD3 bi-specific T cell engager (BiTE) has been approved for relapsed/refractory B-precursor ALL (Acute lymphoblastic leukemia). In addition, CD19 was the target of the first approved CAR-T cell therapy.
Description: The anti-CD19 CAR-T cells are produced by high-titer lentiviral transduction of human primary CD4+CD8+ T cells using the anti-CD19 CAR Lentivirus (CD19 ScFv-CD8-4-1BB-CD3ζ; SIN Vector). These ready-to use CAR-T cells express an anti-CD19 CAR consisting the ScFv of CD19 (clone FMC63) linked to a 2nd generation CAR (Chimeric Antigen Receptor) containing CD8 hinge and transmembrane domains, and the 4-1BB and CD3ζ signaling domains.These CAR-T cells have been validated using flow cytometry (to determine the CAR expression) and co-culture cytotoxicity assays.
Mycoplasma Testing: The cells have been screened to confirm the absence of Mycoplasma species.
Storage Stability: Cells are shipped in dry ice and should immediately be thawed or stored in liquid nitrogen upon receipt. Do not use a -80°C freezer for long term storage.
Supplied As: Each vial contains 2 x 106 cells in 1 ml of CryoStor® CS10)
Warnings: Avoid freeze/thaw cycles. Donors have been screened and determined negative for:- Hepatitis B (anti-HBc EIA, HBsAg EIA)- Hepatitis C (anti-HCV EIA)- Human Immunodeficiency Virus (HIV-1/HIV-2 plus O)- Human T-Lymphotropic Virus (HTLV-I/II)- HIV-1/HCV/HBV- West Nile Virus- Trypanasoma cruziNote: Testing cannot guarantee that any sample is completely virus-free. These cells should be treated as potentially infectious and appropriate biological safety level 2 precautions should be used.
Biosafety Level: BSL-1