Tafasitamab Biosimilar - Research Grade

Human

CD19

>1mg/ml

Human IgG1 (S239D/K274Q/Y296F/Y300F/L309V/I332E/A339T/V397M)-Kappa

Bulk Anti-Human CD19 (SJ25-C1) Antibody (ICH1011), Anti-CD19 (1D3) In Vivo Antibody - Low Endotoxin (ICH1052), Bulk anti-Human CD19 (4G7) Antibody (ICH1237), Anti-Human FMC63 (IB11) Antibody (ICH1258), Inebilizumab Biosimilar - Research Grade (ICH5168), Loncastuximab Biosimilar - Research Grade (ICH5298), Budoprutug Biosimilar - Research Grade (ICH5418), Obexelimab Biosimilar - Research Grade (ICH5719), Tisagenlecleucel Biosimilar - Research Grade (ICH5928)

https://www.imgt.org/mAb-DB/

ICH3002

P15391;P51677

Blue ice

This product is an unconjugated, non-therapeutic recombinant analog of tafasitamab, an Fc-engineered anti-CD19 monoclonal antibody, supplied for research use only. It is a human IgG1/kappa built around the CD19 target, with the characteristic Fc modifications (including S239D and I332E) that enhance FcgammaRIIIa binding and antibody-dependent cell-mediated cytotoxicity and phagocytosis. It is not the clinical drug and is not intended for human or veterinary use. As a research-grade biosimilar analog it is useful as a defined, reproducible reagent for CD19-directed binding and neutralisation assays, as a positive or isotype-matched control in ADCC/ADCP readouts, for benchmarking novel anti-CD19 antibodies and CAR constructs, and for in-vitro and preclinical characterisation of B-cell targeting. It is available in bulk (milligram to gram) formats and in low-endotoxin grades (research grade <1 EU/mg; ultra-low <0.5 EU/mg) suitable for cell-based and in-vivo standard applications. Guidance provided for ichorbio to review. CD19 (UniProt P15391) is a 95 kDa type I transmembrane glycoprotein of the immunoglobulin superfamily, expressed throughout most of B-cell development from the pro-B stage through mature B cells and into early plasmablasts, but lost on terminally differentiated plasma cells and absent from hematopoietic stem cells. It functions as a co-receptor that assembles with CD21, CD81 and CD225 to lower the threshold for B-cell receptor signalling, amplifying downstream PI3K and other pathways to regulate B-cell activation, proliferation and antibody responses. Its broad, B-lineage-restricted, and highly consistent expression across normal and malignant B cells makes CD19 a leading target in B-cell malignancies for antibody, antibody-drug-conjugate, bispecific and CAR-T approaches, and a valuable marker for tracking B-cell populations in research.

B4, CVID3, Leu-12

Detects human CD19

This monoclonal antibody was purified using multi-step affinity chromatography methods such as Protein A or G depending on the species and isotype.

Sterile, preservative-free, solution in PBS. BSA and Azide free.

This biosimilar is stable when stored at 2-8°C. For longer term storage (> 3 months) it is recommended to store this antibody at -20°C or -70°C.

Functional Assays

This biosimilar is for research use only (RUO): it is not for diagnostic or therapeutic procedures and cannot be purchased by patients.

Products are for research use only. Not for use in diagnostic or therapeutic procedures.