KRIBIOLISA™ Infliximab (REMICADE) ELISA

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

The Infliximab (Remicade) ELISA kit is intended for the quantitative determination of Infliximab (Remicade) in serum, plasma and cell culture samples. CE IVD marked

Introduction:
Infliximab is a monoclonal antibody which has high specificity for TNFα, and does not neutralize TNF beta.
Infliximab causes programmed cell death of TNFα-expressing activated T lymphocytes, an important cell type
mediating inflammation; hence it is generally assumed that resolution of activated T cells by Infliximab explains
its efficacy in Crohn's disease.

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

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Infliximab are
pre-coated onto microwells. Samples and standards are pipetted into microwells and human Infliximab
present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase)
conjugated anti-Infliximab antibody is pipetted and incubated. 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 Infliximab in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm.