Recommendations on ELISpot assay validation by the GCC
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: cell therapy cellular immunity ELISpot Enzyme-Linked Immunospot GCC gene therapy global CRO council regulated bioanalysis vaccine validation Read the article Read Full Article Learn. Engage. Connect. Learn | Engage | Connect Read news, updates, and transforming technologies of drug development Recommendations on ELISpot assay Gene therapy, cell therapy and vaccine research have led to.. Read More … Bringing more affordable medicines News release Governments of Canada and Prince Edward Island contribute.. Read More … Solution Quality & Speed. Delivered Immunogenicity Learn More Biosimilar Development Learn.. Read More … Cell-based Assays Cell-based Assays Solutions Cell bank and cell culture Custom method.. Read More … Ready to get started? Consult with a Scientist today! Let’s Talk