Anti-Human CD20 (Ublituximab) – Fc Muted™

This biosimilar antibody is aseptically packaged and formulated in 0.01 M phosphate buffered saline (150 mM NaCl) PBS pH 7.2 - 7.4 with no carrier protein, potassium, calcium or preservatives added. Due to inherent biochemical properties of antibodies, certain products may be prone to precipitation over time. Precipitation may be removed by aseptic centrifugation and/or filtration.

Liquid

Recombinant biosimilar antibodies are manufactured in an animal free facility using only in vitro protein free cell culture techniques and are purified by a multi-step process including the use of protein A or G to assure extremely low levels of endotoxins, leachable protein A or aggregates.

To protect mouse colonies from infection by pathogens and to assure that experimental preclinical data is not affected by such pathogens, all of Leinco’s recombinant biosimilar antibodies are tested and guaranteed to be negative for all pathogens in the IDEXX IMPACT I Mouse Profile.

Functional grade preclinical antibodies may be stored sterile as received at 2-8°C for up to one month. For longer term storage, aseptically aliquot in working volumes without diluting and store at ≤ -70°C. Avoid Repeated Freeze Thaw Cycles.

Research Use Only

2 – 8° C Wet Ice

This non-therapeutic biosimilar antibody uses the same variable region sequence as the therapeutic antibody Ublituximab. TG-1101 targets a unique epitope on the CD20 antigen.

CD20 is a transmembrane protein that is prominently present on the surface of B-cells from the early to mature stages, but notably absent on hematopoietic stem cells, pro-B cells, or plasma cells. Its significance lies in its role in B-cell functions such as activation and differentiation. It is a key target for monoclonal antibodies used in the treatment of B-cell- related diseases and autoimmune conditions. Monoclonal antibodies targeting CD20 have been widely used to treat B-cell lymphomas, leukemias, and autoimmune diseases like rheumatoid arthritis and systemic lupus erythematosus. These antibodies work by selectively targeting and depleting B-cells that express CD20, thereby modulating the immune response and reducing inflammation. This targeted approach has shown promising results in managing various B-cell disorders and has significantly improved the prognosis for patients with these conditions^1,2.

TG-1101, also known as Ublituximab, is a monoclonal antibody that targets the CD20 antigen. This helps enhance the immune responses that can destroy B-cells expressing CD20. Ublituximab is currently being studied for its potential in treating B-cell disorders and autoimmune diseases. It has received its first global approval in the USA for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing- remitting disease, and active secondary progressive disease^3-5.

CD20 is primarily expressed on the surface of B lymphocytes, including both normal and malignant B cells.

Src family tyrosine kinases, MHC class I, II, CD53, CD81, CD82

1. Dabkowska A, Domka K, Firczuk M. Front Immunol. 2024;15:1363102.
2. Shan D, Ledbetter JA, Press OW. Blood. 1998;91(5):1644-1652.
3. Lee A. Drugs. 2023;83(5):455-459.
4. Steinman L, Fox E, Hartung HP, et al. N Engl J Med. 2022;387(8):704-714.
5. Boldrini VO, Mader S, Kümpfel T, Meinl E. Mult Scler Relat Disord. 2023;75:104733.
6. Ublituximab Chimeric Recombinant Monoclonal Antibody (MA5-41938). Accessed August 11, 2024. https://www.thermofisher.com/antibody/product/Ublituximab-Chimeric-Antibody-Recombinant-Monoclonal/MA5-41938