Recombinant proteins and peptides are gaining enormously in therapeutic and prophylactic importance, due to their wide application as biopharmaceutical products. Given the complexity of therapeutic proteins with respect to their large molecular size, their post-translational modifications and the variety of biological materials involved in their manufacturing process, it is highly desirable to characterize them in human models that closely replicate a clinical scenario. Safety concerns may arise from protein-engineering strategies, as well as the presence of impurities or contaminants.
Monocytes are mediators of the innate immune system, and our platform makes it possible to predict their response to pyrogenic contaminants in a physiologically relevant blood environment. Additionally, due to the human specificity of many peptide-derived pharmaceuticals, in vitro assays based on human cells/blood are particularly important to confirm mode of action and assess the risk of potential immunotoxicity.