Recommendations on ELISpot assay validation by the GCC

Abstract

Gene therapy, cell therapy and vaccine research have led to an increased need to perform cellular immunity testing in a regulated environment to ensure the safety and efficacy of these treatments. The most common method for the measurement of cellular immunity has been Enzyme-Linked Immunospot assays. However, there is a lack of regulatory guidance available discussing the recommendations for developing and validating these types of assays. Hence, the Global CRO Council has issued this white paper to provide a consensus on the different validation parameters required to support Enzyme-Linked Immunospot assays and a harmonized and consistent approach to Enzyme-Linked Immunospot validation among contract research organizations.

Keywords: ELISpot; Enzyme-Linked Immunospot; GCC; cell therapy; cellular immunity; gene therapy; global CRO council in bioanalysis; regulated bioanalysis; vaccine; validation.