Rituximab biosimilar, human CD20 monoclonal antibody

Recombinant Humanized IgG1 Monoclonal Antibody.
Isotype: Human IgG1 kappa.
Source: The monoclonal antibody rituximab biosimilar was produced in the Rituximab biosimilar CHO stable cell line.
Specificity/Sensitivity: The monoclonal antibody rituximab biosimilar specifically binds to the human TNF alpha.
Applications: ELISA, neutralization, functional assays such as bioanalytical PK and ADA assays, and those assays for studying biological pathways affected by rituximab.
Form of Antibody: 0.2 uM filtered solution, pH 6.5, no stabilizers or preservatives.
Endotoxin: < 1 EU per 1 mg of the protein by the LAL method.
Purity: >95% by SDS-PAGE under reducing conditions and HPLC.

Shipping: The monoclonal antibody rituximab biosimilar is shipped with ice pack. Upon receipt, store it immediately at the temperature recommended below.
Stability & Storage: Use a manual defrost freezer and avoid repeated freeze-thaw cycles.
12 months from date of receipt, -20 to -70°C as supplied.
1 month from date of receipt, 2 to 8°C as supplied.

Background

B-lymphocyte antigen CD20 encoded by the MS4A1 gene is an activated-glycosylated phosphoprotein on the surface of all B-cells. The function of the membrane protein is to stimulate B-cell immune response, specifically against T-independent antigens though its natural ligand remains unknown. CD20 is important for the development and differentiation of B-cells into plasma cells. CD20 belongs to the membrane-spanning 4A family with common structural features, similar intron/exon splice boundaries, and unique expression patterns among hematopoietic cells and nonlymphoid tissues.

Rituximab, a chimeric anti-CD20 monoclonal antibody, destroys B cells and is used to treat diseases with excessive numbers of B cells, overactive B cells, or dysfunctional B cells, such as many lymphomas, leukemias, transplant rejection, and autoimmune disorders.