Anti-Human IL-6R (CD126) (Satralizumab)

Unknown

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 Satralizumab. SA237 (Satralizumab) is an antagonist of human and cynomolgus monkey IL-6R.

IL-6 is a pleiotropic cytokine that promotes B cell and T cell proliferation and differentiation and is also involved in the inflammatory response¹. In the ‘classic’ signaling paradigm, IL-6 binds to its membrane bound receptor IL-6R to initiate intracellular signaling pathways². Alternatively, in ‘trans-signaling’, IL-6 binds to a soluble form of IL-6R. In both events, a complex set of interactions with membrane-bound or soluble β-receptor glycoprotein 130 (gp130) modulates the downstream signaling pathways. Additionally, IL-6 plays an inflammatory role in autoimmune diseases³ and high IL-6 levels are a feature of cytokine storm and cytokine release syndrome during COVID-19 infection¹. IL-6 signaling can be inhibited by antibodies directed against IL- 6R³.

SA237 (Satralizumab) is a humanized monoclonal recycling antibody that was developed for the treatment of neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system⁴. Satralizumab binds to both membrane and soluble IL-6R, thereby inhibiting IL-6 signaling as well as reducing inflammation and IL-6 mediated autoimmune T cell and B cell activation. Ultimately, B cell differentiation into AQP4-IgG-secreting plasmablasts is prevented. Satralizumab circulation in the body is extended via a novel recycling technology that allows for pH dependent dissociation from IL-6R in the endosome after cellular uptake. Satralizumab is then transported back to the plasma membrane via the recycling endosomal pathway and released into plasma for reuse.

Satralizumab is produced in Chinese hamster ovary cells using recombinant DNA technology⁴. Satralizumab does not cross react with rodent IL-6R⁵.

IL-6R is mainly found on hepatocytes, some leukocytes, and epithelial cells. IL-6R also has a soluble form.

IL-6

1 Cortegiani A, Ippolito M, Greco M, et al. Pulmonology. 27(1):52-66. 2021.
2 Wolf J, Rose-John S, Garbers C. Cytokine. 70(1):11-20. 2014.
3 Sebba A. Am J Health Syst Pharm. 65(15):1413-1418. 2008.
4 Heo YA. Drugs. 80(14):1477-1482. 2020.
5 Katagiri R, Ishihara-Hattori K, Frings W, et al. Birth Defects Res. 109(11):843-856. 2017.
6 Yamamura T, Kleiter I, Fujihara K, et al. N Engl J Med. 381(22):2114-2124. 2019.
7 Traboulsee A, Greenberg BM, Bennett JL, et al. Lancet Neurol. 19(5):402-412. 2020.