Recommendations on ELISpot assay validation by the GCC

Islam R, Vance J & Poirier M et al. | Bioanalysis, 14(4), 187 - 193, (2022) Keywords: • cell therapy • cellular immunity • ELISpot • Enzyme-Linked Immunospot •GCC •gene therapy • global CRO council in bioanalysis • regulated bioanalysis • vaccine • validation 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...