Donanemab Biosimilar - Research Grade

Human

APP

>1mg/ml

IgG1 - kappa

CHO Cells

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https://www.imgt.org/mAb-DB/

ICH3002

P05067

Blue ice

This product is an unconjugated, non-therapeutic recombinant analog of donanemab, supplied for research use only. It is a human IgG1 (kappa) antibody built to recapitulate the antigen-binding specificity of the originator, which recognizes a pyroglutamate-modified, plaque-deposited fragment of amyloid-beta derived from the amyloid precursor protein (APP; UniProt P05067). Because it reproduces binding to this target without being formulated as a clinical drug, it is useful as a reference and control reagent: as a positive/isotype-matched binding control in ELISA and other immunoassays, as a capture or detection reagent for the modified amyloid-beta epitope, for characterizing binding kinetics and cross-reactivity, and in preclinical in-vitro and ex-vivo model systems. It is offered at research grade with low endotoxin (typically <1 EU/mg, with an ultra-low <0.5 EU/mg option) and in bulk milligram-to-gram quantities suitable for assay development, screening, and comparability or biosimilarity workstreams. It is not the clinical product and is not intended for human or veterinary use. All content here is guidance for ichorbio to review. APP (amyloid precursor protein, UniProt P05067) is a ubiquitously expressed type I transmembrane glycoprotein processed by secretases along competing pathways. Non-amyloidogenic processing by alpha- then gamma-secretase precludes intact amyloid-beta, whereas sequential beta-secretase (BACE1) and gamma-secretase cleavage liberates amyloid-beta (Abeta) peptides of varying length, notably Abeta40 and the more aggregation-prone Abeta42. Abeta can undergo N-terminal truncation and post-translational modification, including cyclization of glutamate at position 3 to pyroglutamate (Abeta p3-42). This modified, hydrophobic species is highly aggregation-prone, resistant to degradation, and enriched in insoluble parenchymal plaques characteristic of Alzheimer's disease. Notably, donanemab does not bind full-length APP or soluble monomeric Abeta; its epitope is the deposited, pyroglutamate-modified Abeta fragment. APP itself also has physiological roles in synaptic function, cell adhesion, and neurite outgrowth.

Amyloid-beta precursor protein, amyloid precursor protein

This monoclonal antibody was purified using Protein A

Sterile, preservative-free, solution in PBS. BSA and Azide free.

This biosimilar is stable when stored at 2-8°C. For longer term storage (> 3 months) it is recommended to store this antibody at -20°C or -70°C.

Functional Assays

This biosimilar is for research use only (RUO): it is not for diagnostic or therapeutic procedures and cannot be purchased by patients.

Products are for research use only. Not for use in diagnostic or therapeutic procedures.

3-4 weeks