Abstract

An
in vitro assay model for measuring cytokine induction (cytokine storm)
was developed and implemented as a tool for predicting the potential
immunogenicity of drug candidates in a preclinical setting. In this study,
human primary peripheral blood mononuclear cells (PBMCs) isolated from healthy
donor whole blood were used as predictive models for immunogenicity assessment.
Here, we measured immunogenicity of two representative antibody-based
therapeutics (Alemtuzumab and Cetuximab). Luminex instrument was used to
measure concentration (pg/mL) of cytokine secretion (IFNg, TNFα, IL-4, IL-6, IL-8 and IL-10)
levels in the PBMC supernatant. The response exhibited by Alemtuzumab and
Cetuximab against eight-donors agrees with clinical immunogenicity findings in
the literature. Data from this study supports that these in vitro assays
developed at BioMedha can be used as tools for immunogenicity risk assessment
at an early stage.