Donitabart Biosimilar - Research Grade

Human

ganglioside GD2

>1mg/ml

IgG1 - kappa

CHO Cells

Naxitamab Biosimilar - Research Grade (ICH5164), Dinutuximab Biosimilar - Research Grade (ICH5308)

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

ICH3002

Blue ice

This product is an unconjugated, non-therapeutic recombinant analog of the anti-GD2 antibody donitabart, built around the disialoganglioside GD2 target and supplied strictly for research use only. It is a full-length human IgG1, kappa immunoglobulin produced recombinantly; it is not the clinical drug and is not intended for any human or veterinary use. Because it reproduces the binding specificity of the originator against GD2, it is a convenient tool for in-vitro and preclinical work: as a positive/isotype-matched binding control in ELISA and flow cytometry, a reference reagent for developing and benchmarking anti-GD2 assays, a building block for antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC) and antibody-drug-conjugate (ADC) development workflows, and a standard for characterising GD2-expressing cell lines. It is offered at low endotoxin (research grade typically under 1 EU/mg, ultra-low under 0.5 EU/mg) and in bulk milligram-to-gram quantities to support screening campaigns, assay validation and in-vitro standard curves. Guidance is provided for ichorbio to review. GD2 is a disialoganglioside, a glycosphingolipid carrying two sialic acid residues, embedded in the outer leaflet of the plasma membrane rather than a protein antigen (hence no UniProt accession). In healthy tissue its expression is restricted, largely to central and peripheral neurons, skin melanocytes and peripheral nerve fibres. GD2 is markedly overexpressed on tumors of neuroectodermal origin, most notably neuroblastoma, and also melanoma, retinoblastoma, small-cell lung cancer, osteosarcoma and some soft-tissue sarcomas, where it contributes to cell adhesion, motility and signalling. This tumor-associated pattern makes it a validated immunotherapy target: antibodies binding GD2 can trigger antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity and direct apoptosis of GD2-positive cells. Clinically validated anti-GD2 agents include dinutuximab and naxitamab for high-risk neuroblastoma, establishing GD2 as a well-characterised target for antibody-based approaches.

This monoclonal antibody was purified using Protein A

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.

3-4 weeks