Immunogenicity studies are an important consideration as they helps in analysing the strength or magnitude of immune response. Therapeutic proteins may contain multiple impurities which may be either variant of product or derived from cell substrate or manufacturing process. Presence of such impurities even at trace level has the potential to activate innate immune cells causing expression of cytokines or chemokines.

At VIMTA, we offer immunogenicity studies and cytokine profiling for synthetic peptide drugs for ANDA filing which are conducted in accordance with regulatory guidelines.