Anti-Human Amyloid-β (Donanemab) – 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 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 Donanemab. Donanemab binds to the insoluble, modified, N- terminal truncated form of the β-amyloid.

Amyloid-β (Aβ) is a peptide that accumulates in the brains of individuals with Alzheimer’s disease, forming plaques that are a hallmark of the condition. These plaques are believed to contribute to the neurodegenerative processes seen in Alzheimer’s by disrupting cell function and triggering inflammatory responses. Amyloid-β is derived from the amyloid precursor protein (APP) through enzymatic cleavage. The aggregation of Aβ into oligomers and fibrils is a key pathological feature of Alzheimer’s disease, making it a significant target for therapeutic interventions aimed at reducing or preventing plaque formation^1,2.

LY3002813, known as Donanemab, is a human IgG1, kappa monoclonal antibody designed to target amyloid-beta plaques, which are linked to Alzheimer's disease. By binding to these plaques, Donanemab aims to reduce their accumulation and may slow disease progression. It is primarily used in clinical research and trials, with studies demonstrating its potential to lower amyloid plaque levels and improve cognitive function in early-stage Alzheimer's patient^3-7.

Amyloid-beta (Aβ) circulates in plasma, cerebrospinal fluid (CSF), and brain interstitial fluid (ISF), primarily as soluble Aβ40.

APBB1-KAT5, TNFRSF21, binds transient metals such as copper, zinc, and iron

1. Arndt JW, Qian F, Smith BA, et al. Sci Rep. 2018;8(1):6412.
2. Sevigny J, Chiao P, Bussière T, et al. Nature. 2016;537(7618):50-56.
3. Song T, Wang Y, Silverglate BD, Grossberg GT. Expert Opin Drug Metab Toxicol. 2024;20(6):411-417.
4. Shukla AK, Misra S. J Basic Clin Physiol Pharmacol. 2024;35(1-2):25-29.
5. Sims JR, Zimmer JA, Evans CD, et al. JAMA. 2023;330(6):512-527.
6. Sato S, Hatakeyama N, Fujikoshi S, Katayama S, Katagiri H, Sims JR. Neurol Ther. 2024;13(3):677-695.
7. Mintun MA, Lo AC, Duggan Evans C, et al. N Engl J Med. 2021;384(18):1691-1704.