Brolucizumab ELISA Kit

Brolucizumab is the first and only single-chain variable fragment (scFv) targeting vascular endothelial growth factor (VEGF) -A. It has a smaller molecular weight (26 kDa) . The mAb is undergoing evaluation as a treatment for neovascular age-related macular degeneration (nAMD) . In June 2017, Novartis announced that the primary efficacy endpoint of non-inferiority to aflibercept (EYLEA®) in mean change in best-corrected visual acuity from baseline to week 48 was met in the Phase 3 HAWK (NCT02307682) and HARRIER (NCT02434328) studies, which included more than 1,800 patients. The two studies compared the efficacy and safety of intravitreal injections of 6 mg brolucizumab or 3 mg brolucizumab (HAWK study only) versus 2 mg aflibercept in patients with nAMD. Of patients receiving 6 mg brolucizumab, 57% (HAWK) and 52% (HARRIER) were maintained exclusively on an every 12 week dosing interval immediately following the loading phase and continuing through week 48.54 Key secondary endpoints were also met. Novartis is developing a competitive, low cost of goods formulation, and expects to complete the PK study with antibody derived from the final manufacturing process to enable filing in 2018.

PRINCIPLE OF THE ASSAY This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant human VEGF antigen has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Brolucizumab in the sample competitively binds to the pre-coated protein with biotin-labeled Brolucizumab. After washing away any unbound substances, Streptavidin-HRP is added to the wells. Following a wash to remove any unbound enzyme reagent, a substrate solution is added to the wells and color develops in inversely proportion to the amount of Brolucizumab bound in the initial step. The color development is stopped and the intensity of the color is measured.

Brolucizumab

ESBA-1008, ESBA1008, RTH258, CAS: 1531589-13-5

Colorimetric

Quantitative

Plasma, Serum

1.5625 ng/mL — 100 ng/mL

80-120%

2-8 °C

The stability of ELISA kit is determined by the loss rate of activity. The loss rate of this kit is less than 10% prior to the expiration date under appropriate storage condition.

For Research Use Only.