KRIBIOLISA™ Teclistamab ELISA

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

Enzyme Immunoassay for the quantitative determination of Teclistamab in serum and plasma

Introduction:
Teclistamab is a bispecific T-cell engager antibody that targets both B-cell maturation antigen (BCMA)
expressed on the surface of myeloma cells and the CD3 receptor expressed on the surface of T cells. The FDA
in Oct 2022 granted approval to Janssen Biotech’s Teclistamab (TECVAYLI) for treatment of relapsed or
refractory multiple myeloma, marking a new class of therapy now available for patients whose disease had
progressed on other types of therapy.

Intended Use:
The KRIBIOLISATM Teclistamab ELISA is used as an analytical tool for quantitative determination of
Teclistamab in human serum and plasma.

Principle:
The method employs indirect sandwich ELISA technique. Recombinant BCMA protein is pre-coated onto
microwells. Samples and Teclistamab standards are pipetted into microwells and bound by the capture protein.
After incubation the wells are washed and followed by addition of HRP-conjugated CD3 protein into each well and
incubated to form a complex. After washing microwells in order to remove any non-specific binding, the substrate
solution (TMB) is added to microwells and color develops proportionally to the amount of Teclistamab in the
sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.