Functional and safety assessments of biologics prior to first-in-human (FIH) is key to understand the mode-of-action and safety profile. We have made use of an ex-vivo whole blood assay for its potential in assessment of antibody-based drug candidates.
Therapeutic monoclonal antibodies are biological drugs developed for the treatment of human diseases such as cancer, autoimmune diseases, and inflammatory related heart-problems along with geriatric diseases. Apart from the therapeutic effect, monoclonal antibodies can cause unexpected side effects such as activation of immune cells and release of factors that collectively induce a severe systemic immune activation, called cytokine release syndrome (CRS). The affected patient experience chills, muscle- and joint-aches, fever, nausea, vomiting and in severe cases breathing difficulties and organ failures. Because of these side effects, such as CRS, all biological drugs require safety testing before a FIH trial can take place.
Read more: http://atlasofscience.org/profiling-biologics-in-circulating-human-whole-blood/