Combined in Silico and Experimental Research to Test the Possible Immunogenicity of a New Complex Biologic Medical Drug (PRS CK STORM) |Biomedgrid

Treatments with biological medicines tend to have a relative efficacy that decreases mainly for two reasons. Firstly, drugs based on the use of high doses of proteins, especially those manufactured artificially or semi-artificially by biotechnology, tend to produce immunogenicity reactions and generate Antidrug antibodies (ADAs) in a certain percentage of the patients to whom they are applied. Secondly, a therapeutic approach based on the single use of a monoclonal antibody does not cover possible positive or negative feedback mechanisms in parallel associated metabolic pathways. Our research group has developed a new biotechnological platform that allows the production of complex biological drugs for allogeneic use, based on the generation of macrophage co-culture with stromal cells or primary cells, with indirect contact. This article describes the in silico, in vitro and in vivo tests carried out with the drug PRS CK STORM, a conditioned medium of M2 macrophages produced by co-culture with indirect contact with MSCs from fat, the results of which demonstrate the absence of immunogenicity of the product applied at the doses tested, demonstrating the possible safety of the drug.