KRIBIOLISA™ Ranibizumab (LUCENTIS) ELISA

Krishgen- Biopharma-PK-ADA; Biosimilars / Biotherapeutics; Pharmacokinetic Assays / Bioassays

The Ranibizumab (Lucentis) kit is an assay intended for the quantitative determination of Ranibizumab (Lucentis) in serum, plasma and cell culture samples.



Key features:

< ul>
< li> uses highly specific monoclonal anti-idiotypic antibodies< /li>
< li> calibrators used is commerically available daratumumab injection itself< /li>
< li> Recovery: 80-120%< /li>
< li> Precision CV & lt; 15%< /li>
< /ul>

Introduction:
Ranibizumab (Lucentis) is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and
inhibits vascular endothelial growth factor A (VEGF-A). VEGF is a biochemical signal protein that promotes
angiogenesis throughout the body and in the eye. Through binding to VEGF-A, ranibizumab interrupts the
interaction of VEGF with its receptors, and thus prevents the subsequent growth of new blood vessels.

Intended Use:
The KRIBIOLISA™ Ranibizumab (LucentisTM) ELISA is used as an analytical tool for quantitative determination
of Ranibizumab in serum, plasma and cell culture supernatant.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Ranibizumab are
pre-coated onto microwells. HRP Conjugate, Samples / Standards are pipetted into microwells and human
Ranibizumab present in the sample are bound by the capture antibody. After washing microwells in order to
remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color
develops proportionally to the amount of Ranibizumab in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm.