Anti-Human Fibroblast Growth Factor 23 (Burosumab)

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 biosimilar 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 -80°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 Burosumab. Burosumab (KRN-23) is a human monoclonal antibody that specifically targets fibroblast growth factor 23 (FGF23).

Fibroblast growth factor 23 (FGF23) is a hormone produced by bone cells that plays a key role in regulating phosphate levels in the body. Excessive FGF23 production leads to hypophosphatemic conditions like rickets and osteomalacia. Disorders such as X-linked hypophosphatemia (XLH) and tumor-induced osteomalacia (TIO) are characterized by elevated FGF23 levels, resulting in low phosphate levels and impaired bone health. Measuring FGF23 levels is critical for diagnosing these hypophosphatemic diseases and guiding treatment decisions^1-3.

Burosumab (KRN23) is a fully human monoclonal antibody that binds to and neutralizes excess FGF23, helping restore phosphate balance. Clinical trials have shown burosumab to be effective in treating both XLH and TIO in children and adults, improving serum phosphate levels, bone turnover, fracture healing, and reducing pain. Approved for use in these conditions, burosumab offers a targeted therapy that addresses the underlying cause of FGF23-related disorders. Ongoing studies continue to explore its long-term safety and efficacy, highlighting its potential for sustained clinical benefits^2,4,5.

FGF23 is primarily produced by osteocytes and osteoblasts in the bone. It acts mainly on the kidneys to regulate phosphate reabsorption and vitamin D metabolism. FGF23 can also be found in other tissues, such as the liver, heart, and brain, but its highest expression is in the bone.

FGFR1, FGFR2, FGFR3, FGFR4

1. Fukumoto S. J Mol Endocrinol. 2021;66(2):R57-R65.
2. Imanishi Y, Ito N, Rhee Y, et al. J Bone Miner Res. 2021;36(2):262-270.
3. Athonvarangkul D, Insogna KL. Calcif Tissue Int. 2021;108(1):143-157.
4. Schindeler A, Biggin A, Munns CF. Front Endocrinol (Lausanne). 2020;11:338.
5. Lamb YN. Burosumab: First Global Approval. Drugs. 2018;78(6):707-714.